Devices, systems and methods for locating and interacting with medicament delivery systems

ABSTRACT

In some embodiments, a method includes establishing a communications link between a computing device and an adapter. The adapter is configured to receive at least a portion of a medicament delivery device. A wireless signal is received to maintain the communications link. A relative position between the computing device and the adapter is determined. An alarm is produced when the wireless signal is not received within a time period. The alarm is based on the relative position between the computing device and the adapter.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/752,045, filed Jun. 26, 2015, entitled “Devices, Systems and Methodsfor Locating and Interacting with Medicament Delivery Systems,” which isa continuation of International Application No. PCT/US2013/077996, filedDec. 27, 2013, which claims priority to U.S. Provisional ApplicationSer. No. 61/746,308, entitled “Devices, Systems and Methods for Locatingand Interacting with Medicament Delivery Systems,” filed Dec. 27, 2012,each of which is incorporated herein by reference in its entirety.

BACKGROUND

The invention relates generally to a medical device, and moreparticularly to a medicament delivery device, and/or a simulatedmedicament delivery device having a locating feature, as well as devicesfor interacting with such medicament delivery devices and/or simulatedmedicament delivery devices.

Exposure to certain substances, such as, for example, peanuts,shellfish, bee venom, certain drugs, toxins, and the like, can causeallergic reactions in some individuals. Such allergic reactions can, attimes, lead to anaphylactic shock, which can cause a sharp drop in bloodpressure, hives, and/or severe airway constriction. Accordingly,responding rapidly to mitigate the effects from such exposures canprevent injury and/or death. For example, in certain situations, aninjection of epinephrine (i.e., adrenaline) can provide substantialand/or complete relief from the allergic reaction. In other situations,for example, an injection of an antidote to a toxin can greatly reduceand/or eliminate the harm potentially caused by the exposure. Becauseemergency medical facilities may not be available when an individual issuffering from an allergic reaction, some individuals carry a medicamentdelivery device, such as, for example, an auto-injector, to rapidlyself-administer a medicament in response to an allergic reaction.

As another example, naloxone is a medicament that prevents and/orreverses the effects of opioids. Known formulations of naloxone can beused, for example, to treat respiratory depression and other indicationsthat result from opioid toxicity. For example, known formulations fornaloxone can be used to reverse and/or mitigate the effects of anoverdose of a drug containing opioids, such as, for example, heroin. Insuch situations, it is desirable to deliver the naloxone formulationquickly and in a manner that will produce a rapid onset of action. Knownmethods for delivering naloxone intranasally or via injection, however,often involve completing a series of operations that, if not doneproperly, can limit the effectiveness of the naloxone formulation.Moreover, because naloxone is often administered during an emergencysituation, even experienced and/or trained users may be subject toconfusion and/or panic, thereby compromising the delivery of thenaloxone formulation.

As yet another example, glucagon is a medicament that is administered totreat patients suffering from hypoglycemia. In certain situations, theonset of hypoglycemia can cause the patient to lose motor coordinationand/or lose consciousness. Thus, glucagon is often administered by acare giver during an emergency situation.

In the above-identified examples, as we well as other instances, theindividual requiring the injection may be incapacitated and may unableto inform bystanders of the nature of the medical emergency, that amedicament delivery device is available, and/or how to use themedicament delivery device. If bystanders remain unaware of theavailability and location of the medicament delivery device, or areunable to administer the medicament, important medical aid may not bedelivered. In addition, to actuate some known medicament deliverydevice, the user may be required to execute a series of operations. Forexample, to actuate some known auto-injectors, the user must remove aprotective cap, remove a locking device, place the auto-injector in aproper position against the body and then press a button to actuate theauto-injector. Failure to complete these operations properly can resultin an incomplete injection and/or injection into an undesired locationof the body. In certain instances, for example, users who have becomeconfused in the operation of some known auto-injectors haveinadvertently injected the medicament into their thumb by improperlypositioning the auto-injector.

The likelihood of improper use of known medicament delivery devices canbe compounded by the nature of the user and/or the circumstances underwhich such devices are used. For example, many users are not trainedmedical professionals and may have never been trained in the operationof such devices. Moreover, in certain situations, the user may not bethe patient, or primary caregiver, and may therefore have no experiencewith the medicament delivery device. Similarly, because some knownmedicament delivery devices are configured to be used relativelyinfrequently in response to an allergic reaction or the like, even thoseusers familiar with the device and/or who have been trained may not bewell practiced at operating the device. Finally, such devices are oftenused during an emergency situation, during which even experienced and/ortrained users may be subject to confusion, panic, and/or thephysiological effects of the condition requiring treatment.

Some known medicament delivery devices include printed instructions toinform the user of the steps required to properly deliver themedicament. Such printed instructions, however, can be inadequate forthe class of users and/or the situations described above. Moreover,because some known medicament delivery devices, such as, for example,auto-injectors, pen injectors, inhalers or the like, can be compact,such printed instructions may be too small to read and comprehend duringan emergency situation.

Some known medicament delivery devices are associated with simulatedmedicament delivery devices (e.g., “trainers”) to provide a method forusers to practice using the medicament delivery device without beingexposed to the medicament and/or needles typically contained therein.Such simulated medicament delivery devices, however, can also includeinadequate use instructions as described above.

Monitoring the patient's compliance with known medicament deliverydevices can also be problematic. For example, some known treatmentregimens include multiple doses of a medicament that must beadministered in a timely fashion and/or in a particular order to ensureeffectiveness (e.g., certain vaccination regimens). Thus, monitoring thepatient's compliance is an important aspect in ensuring that thetreatment method will be effective. Some known medicament deliverysystems include a medicament delivery device and an electronic system toassist the user in setting the proper dosage and/or maintaining acompliance log. Such known medicament delivery systems and theaccompanying electronic systems can be large and therefore notconveniently carried by the user. Such known medicament delivery systemsand the accompanying electronic systems can also be complicated to useand/or expensive to manufacture. Moreover, some known medicamentdelivery systems include sensors disposed within the medicament deliverypath, which can interfere with the delivery, result in contamination, orthe like.

Thus, a need exists for medicament delivery systems and/or devices thatallow a medicament delivery device to be quickly identified and located,and provide instructions that can be easily understood by a user in anytype of situation. Additionally, a need exists for simulated medicamentdelivery systems and/or devices that can provide instructions and thatcan be reused multiple times. Moreover, a need exists for medicamentdelivery systems and/or devices that can provide compliance informationassociated with the use of the device and/or that can communicateelectronically with other communications devices.

SUMMARY

System and methods to facilitate wireless communications with medicamentdelivery devices and simulated medicament delivery devices are describedherein. In some embodiments, a method includes establishing acommunications link between a computing device and an adapter. Theadapter is configured to receive at least a portion of a medicamentdelivery device. A wireless signal is received to maintain thecommunications link. A relative position between the computing deviceand the adapter is determined. An alarm is produced when the wirelesssignal is not received within a time period. The alarm is based on therelative position between the computing device and the adapter.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic illustration of a medicament delivery deviceaccording to an embodiment of the invention.

FIG. 2 is a schematic illustration of a medicament delivery deviceaccording to an embodiment of the invention.

FIGS. 3 and 4 are perspective views of a medical injector according toan embodiment of the invention, in a first configuration.

FIG. 5 is a front view of the medical injector illustrated in FIG. 3with the cover removed.

FIG. 6 is a back view of the medical injector illustrated in FIG. 3 withthe cover removed.

FIG. 7 is a front view of a portion of the medical injector illustratedin FIG. 3.

FIG. 8 is a perspective view of a portion of the medical injectorillustrated in FIG. 3.

FIG. 9 is a bottom perspective view of a housing of the medical injectorillustrated in FIG. 3.

FIG. 10 is a top perspective view of a housing of the medical injectorillustrated in FIG. 3.

FIG. 11 is a perspective view of a proximal cap of the medical injectorillustrated in FIG. 3.

FIG. 12 is a front view of a medicament delivery mechanism of themedical injector illustrated in FIG. 3.

FIG. 13 is a back view of an electronic circuit system of the medicalinjector illustrated in FIG. 3.

FIG. 14 is a front view of a portion of the electronic circuit system ofthe medical injector illustrated in FIG. 13.

FIG. 15 is a side view of the electronic circuit system of the medicalinjector illustrated in FIG. 13.

FIG. 16 is a front view of an electronic circuit system housing of themedical injector illustrated in FIG. 13.

FIG. 17 is a perspective view of the electronic circuit system housingof the medical injector illustrated in FIG. 16.

FIG. 18 is a perspective view of a battery clip of the medical injectorillustrated in FIG. 13.

FIG. 19 is a perspective view of a portion of an electronic circuitsystem of the medical injector illustrated in FIG. 3, in a firstconfiguration.

FIG. 20 is a front view of the medical injector illustrated in FIG. 3 ina first configuration showing the electronic circuit system.

FIGS. 21, 22, and 23 are front views of a portion of the electroniccircuit system of the medical injector labeled as Region Z in FIG. 20 ina first configuration, a second configuration, and a thirdconfiguration, respectively.

FIGS. 24 and 25 are perspective views of a cover of the medical injectorillustrated in FIG. 3.

FIG. 26 is a perspective view of a safety lock of the medical injectorillustrated in FIG. 3.

FIG. 27 is a front view of the safety lock of the medical injectorillustrated in FIG. 26.

FIG. 28 is a bottom view of the safety lock of the medical injectorillustrated in FIG. 26.

FIG. 29 is a perspective view of a needle sheath of the safety lock ofthe medical injector illustrated in FIG. 26.

FIG. 30 is a perspective view of a base of the medical injectorillustrated in FIG. 3.

FIG. 31 is a front view of the base of the medical injector illustratedin FIG. 3.

FIG. 32 is a back view of the medical injector illustrated in FIG. 3 ina second configuration.

FIG. 33 is a back view of the medical injector illustrated in FIG. 3 ina third configuration.

FIG. 34 is a back view of the medical injector illustrated in FIG. 3 ina fourth configuration.

FIG. 35 is a schematic diagram of a monitoring device, a locator device,and a medicament delivery device according to an embodiment.

FIG. 36 is a schematic diagram of a locator device, a medicamentdelivery device and a medicament container according to an embodiment.

FIGS. 37 and 38 are a signal diagrams representing communicationsbetween a patient, a monitoring device, a communication device, alocator device, a medicament delivery device, and a user according to anembodiment.

FIGS. 39 to 41 are isometric views of a kit containing a medicamentcontainer in a first configuration, a second configuration, and a thirdconfiguration, respectively, according to an embodiment.

FIG. 42 is a schematic diagram showing the interactions between apatient/user, a medicament delivery device, a docking case, acommunication device, and a communication network according to anembodiment.

FIGS. 43 and 44 are schematic diagrams of a docking case coupled to amedicament delivery device and a communication device in a firstconfiguration and a second configuration, respectively, according to anembodiment.

DETAILED DESCRIPTION

This application is related to U.S. Pat. No. 8,172,082, entitled“Devices Systems and Methods for Medicament Delivery,” filed Feb. 5,2007, and U.S. Pat. No. 8,231,573, entitled “Medicament Delivery DeviceHaving an Electronic Circuit System,” filed May 12, 2008, each of whichis incorporated herein by reference in its entirety.

The medicament delivery systems shown and described herein can be usedin conjunction with any suitable medicament delivery device and/ormedicament container such that the medicament delivery device and/ormedicament container can be easily accessed, identified and located, asdescribed herein. In some embodiments, the medicament delivery devicecan be a medical injector, such as a pen injector, a prefilled syringe,an auto-injector or the like.

As one example, FIG. 1 is a schematic illustration of a medical injector1000, according to an embodiment of the invention. The medical injector1000 includes a housing 1110, a medicament container 1560, a medicamentdelivery member 1512 and an electronic circuit system 1900. The housing1110 includes a sidewall 1148 that defines a first region 1157 and asecond region 1153 within the housing 1110. More particularly, thesidewall 1148 physically isolates the first region 1157 from the secondregion 1153. Said another way, the sidewall 1148 is devoid of openingssuch that the first region 1157 is fluidically and/or physicallyisolated from the second region 1153. Said yet another way, the sidewall1148 is disposed between the first region 1157 and the second region1153 such that the first region 1157 is separated from the second region1153. Although the first region 1157 and the second region 1153 areshown in FIG. 1 as being two-dimensional areas, in some embodiments, thefirst region 1157 and/or the second region 1153, can be fully enclosedvolumes within the housing, and/or volumes within the housing 1110having an opening to an area outside of the housing. Similarly stated,the first region and/or the second region can be cavities, defined bythe housing 1110 and/or the sidewall 1148.

The medicament container 1560, which can be, for example, a pre-filledcartridge, a prefilled syringe, a vial, an ampule or the like, isdisposed within the first region 1157 of the housing 1110. At least aportion of the medicament delivery member 1512 is disposed within thefirst region 1157 of the housing 1110. In some configurations, themedicament delivery member 1512 can be in fluid communication with themedicament container 1560. In this manner, a medicament can be conveyedfrom the medicament container 1560 to a region outside the housing 1110via the medicament delivery member 1512. The medicament delivery member1512 can include, for example, a needle and/or a nozzle.

At least a portion of the electronic circuit system 1900 is disposedwithin the second region 1153 of the housing 1110. Accordingly, theportion of the electronic circuit system 1900 is disposed within thehousing 1110 such that the portion of the electronic circuit system 1900is fluidically and/or physically isolated from the medicament container1560 and/or the medicament delivery member 1512.

The electronic circuit system 1900 is configured to output an electronicoutput OP1 associated with a use of the medical injector 1000. Forexample, in some embodiments, the electronic output OP1 can beassociated with an instruction for using the medical injector 1000. Inother embodiments, the electronic output OP1 can be a post-useinstruction, such as, for example, a recorded message notifying the userthat the injection is complete, instructing the user on post-injectiondisposal and safety procedures, instructing the user to seekpost-injection medical treatment, and/or the like. In yet otherembodiments, the electronic output OP1 can be associated with thepatient's compliance in using medical injector 1000, such as, alertingthe user when to use the medical injector, outputting use of the medicalinjector, locating the medical injector, and/or the like. In someembodiments, the electronic output OP1 can be associated with anactuation of the medical injector 1000. Said another way, the electroniccircuit system 1900 can be configured to output the electronic outputOP1 in response to actuation of the medical injector 1000.

The electronic output OP1 can be, for example, a visual output such as,for example, a text message to display on a screen (not shown), and/oran LED. In some embodiments, the electronic output OP1 can be an audiooutput, such as, for example, recorded speech, a series of tones, and/orthe like. In other embodiments, the electronic output OP1 can be awireless signal configured to be received by a remote device.

The medical injector 1000 can be any suitable medical injector forinjecting medicament into a body of a patient. For example, the medicalinjector 1000 can be a syringe, pen injector, auto-injector or the like.In some embodiments, the medical injector 1000 can be a chronic-careinjector. Said another way, the medical injector 1000 can be a reusabledevice containing multiple doses of medicament. For example, a medicalinjector 1000 having multiple doses of medicament can be used to manageinsulin delivery or the delivery of other medicaments (e.g., to treatMultiple Sclerosis, Anemia, Rheumatoid Arthritis, Diabetes, Seizures,Osteoporosis or the like), which can require daily, weekly, and/ormonthly injections. In other embodiments, the medical injector 1000 canbe a single-use device. Said another way, the medical injector 1000 cancontain a single dose of medicament. In some embodiments, medicalinjector 1000 can include the same dosage of a medicament, and can beprescribed as a part of a chronic-care medicament regimen, clinicaltrial, or the like. In other embodiments, medical injector 1000 caninclude different dosages, multiple doses and/or different medicamentcompositions.

The sidewall 1148 can be any suitable structure to isolate the firstregion 1157 within the housing 1110 from the second region 1153 withinthe housing 1110. In some embodiments, the sidewall 1148 can be rigid.In other embodiments, the sidewall 1148 can be a movable member such as,for example, a piston. In yet other embodiments, the sidewall 1148 canbe a flexible member such as, for example, a diaphragm. In someembodiments, the sidewall 1148 can be constructed from a transparentmaterial such that light can pass from the first region 1157 to thesecond region 1153, and vice versa. A transparent sidewall can be usedin conjunction with an optical sensor. The sidewall 1148 can beintegrally formed with the housing 1110 or can be formed separately fromthe housing 1110.

The electronic circuit system 1900 can include any suitable electroniccomponents operatively coupled to produce and/or output the electronicoutput OP1 and/or to perform the functions described herein. Theelectronic circuit system 1900 can be similar to the electronic circuitsystems described in U.S. patent application Ser. No. 11/621,236,entitled “Devices, Systems and Methods for Medicament Delivery,” filedJan. 9, 2007, which is incorporated herein by reference in its entirety.

FIG. 2 is a schematic illustration of a medicament delivery device 2000that can be used in conjunction with the systems and methods describedherein. The medicament delivery device 2000 includes a housing 2110, amedicament container 2560, a medicament delivery member 2512 and anelectronic circuit system 2900. The medicament container 2560, which canbe, for example, a pre-filled cartridge, a vial, an ampule or the like,is disposed within the housing 2110. At least a portion of themedicament delivery member 2512 is disposed within the housing 2110. Themedicament delivery member 2512 can include any suitable memberconfigured to convey a medicament from the medicament container 2560 toa location within a patient's body. For example, in some embodiments,the medicament delivery member 2512 can be a needle, a nozzle, and/or aninhaler mouth piece.

In use, the medicament delivery member 2512 can be in fluidcommunication with the medicament container 2560. In this manner, themedicament delivery member 2512 and the medicament container 2560 candefine a medicament delivery path 2505 through which a medicament 2568can be conveyed from the medicament container 2560 to a location outsidethe housing 2110 via the medicament delivery member 2512 as shown byarrow AA. In some embodiments, the medicament delivery path 2505 caninclude portions of a lumen defined by the medicament delivery member2512 and/or the connection between the medicament delivery member 2512and the medicament container 2560.

The electronic circuit system 2900 is coupled to the housing 2110 and isfluidically and/or physically isolated from the medicament delivery path2505. The electronic circuit system 2900 is configured to output anelectronic output OP2 in response to a delivery of the medicament 2568via the medicament delivery path 2505. In this manner, the electroniccircuit system 2900 can output the electronic output OP2 in anunobtrusive manner and/or without impeding the delivery of themedicament 2568 through the medicament delivery path 2505. In someembodiments, for example, the electronic output OP2 can be a post-useinstruction, such as, for example, a recorded message notifying the userthat the injection is complete, instructing the user on post-injectiondisposal and safety procedures, instructing the user on post-injectionmedical treatment, and/or the like. In other embodiments, the electronicoutput OP2 can be associated with the patient's compliance in using themedicament delivery device 2000. For example, in some embodiments, theelectronic output OP2 can be a signal sent to a compliance trackingmonitor to record the data and/or time of use of the medicament deliverydevice 2000.

The electronic output OP2 can be, for example, a visual output such as,for example, a text message to display on a screen (not shown), and/oran LED. In some embodiments, the electronic output OP2 can be an audiooutput, such as, for example, recorded speech, a series of tones, and/orthe like. In other embodiments, the electronic output OP2 can be awireless signal configured to be received by a remote device.

The medicament delivery device 2000 can be any suitable medicamentdelivery device for delivering the medicament 2568 to a body of apatient. For example, the medicament delivery device 2000 can be asyringe, pen injector, auto-injector, inhaler or the like. In someembodiments, the medicament delivery device 2000 can be a chronic-caredelivery device. Said another way, the medicament delivery device 2000can be a reusable device containing multiple doses of medicament 2568.In other embodiments, the medicament delivery device 2000 can be asingle-use device. Said another way, the medicament delivery device 2000can contain a single dose of medicament 2568.

The electronic circuit system 2900 can include any suitable electroniccomponents operatively coupled to produce and/or output the electronicoutput OP2 and/or to perform the functions described herein. Theelectronic circuit system 1900 can be similar to the electronic circuitsystem 1900 as described above with reference to FIG. 1.

FIGS. 3-34 show a medical injector 4000 as another example of a deliverydevice that can be used in conjunction with and/or as a part of thedelivery systems and methods described herein. FIGS. 3-4 are perspectiveviews of the medical injector 4000 in a first configuration (i.e., priorto use). The medical injector 4000 includes a housing 4110, a deliverymechanism 4500 (see e.g., FIG. 12), an electronic circuit system 4900(see e.g., FIGS. 13-23), a cover 4200 (see e.g., FIGS. 24-25), a safetylock 4700 (see e.g., FIGS. 26-29) and a base 4300 (see e.g., FIGS.30-31). A discussion of the components of the medical injector 4000 willbe followed by a discussion of the operation of the medical injector4000.

As shown in FIGS. 5-11, the housing 4110 has a proximal end portion 4140and a distal end portion 4120. The housing 4110 defines a first statusindicator aperture 4150 and a second status indicator aperture 4151. Thefirst status indicator aperture 4150 defined by the housing 4110 islocated on a first side of the housing 4110, and the second statusindicator aperture 4151 of the housing 4110 is located on a second sideof the housing 4110. The status indicator apertures 4150, 4151 can allowa patient to monitor the status and/or contents of a medicamentcontainer 4560. For example, by visually inspecting the status indicatorapertures 4150, 4151, a patient can determine whether the medicamentcontainer 4560 contains a medicament and/or whether a medicament hasbeen dispensed.

As shown in FIGS. 9 and 10, the housing 4110 defines a gas cavity 4154,a medicament cavity 4157 and an electronic circuit system cavity 4153.The gas cavity 4154 has a proximal end portion 4155 and a distal endportion 4156. The gas cavity 4154 is configured to receive the gascontainer 4570 and the release member 4540 of the medicament deliverymechanism 4500 (see e.g., FIG. 12) as described in further detailherein. The proximal end portion 4155 of the gas cavity 4154 isconfigured to receive the gas container retention member 4580 of theproximal cap 4112 of the housing 4110, as described in further detailherein. The gas cavity 4154 is in fluid communication with themedicament cavity 4157 via a gas passageway 4144, as described infurther detail herein, and the gas cavity 4154 is in fluid communicationwith a region outside the housing 4110 via a safety lock aperture 4128.

The medicament cavity 4157 is configured to receive a portion of thedelivery mechanism 4500. In particular, the carrier 4520, the moveablemember 4530 and the needle 4512 of the medicament delivery mechanism4500 are movably disposed in the medicament cavity 4157. The medicamentcavity 4157 is in fluid communication with a region outside the housing4110 via a needle aperture 4122.

The electronic circuit system cavity 4153 is configured to receive theelectronic circuit system 4900. The housing 4110 has protrusions 4149(see e.g., FIG. 8) configured to stabilize the electronic circuit system4900 when the electronic circuit system 4900 is disposed within theelectronic circuit system cavity 4153. The housing 4110 also definesconnection apertures 4152 configured to receive connection protrusions4171 of the electronic circuit system 4900, and aperture 4145 (see e.g.,FIG. 6) configured to receive a portion of a protrusion 4174 of theelectronic circuit system 4900. In this manner, the electronic circuitsystem 4900 can be coupled to the housing 4110 within the electroniccircuit system cavity 4153. In other embodiments, the electronic circuitsystem 4900 can be coupled within the electronic circuit system cavity4153 by other suitable means such as an adhesive, a clip and/or thelike.

The electronic circuit system cavity 4153 is fluidically and/orphysically isolated from the gas cavity 4154 and/or the medicamentcavity 4157 by a sidewall 4148. The sidewall 4148 can be any suitablestructure to isolate the electronic circuit system cavity 4153 withinthe housing 4110 from the gas cavity 4154 and/or the medicament cavity4157 within the housing 4110. Similarly, the gas cavity 4154 and themedicament cavity 4157 are separated by a sidewall 4146. In someembodiments, sidewall 4146 can be similar to the sidewall 4148, whichisolates the gas cavity 4154 and the medicament cavity 4157 from theelectronic circuit system cavity 4153. In other embodiments the gascavity 4154 can be fluidically and/or physically isolated from themedicament cavity 4157.

The proximal end portion 4140 of the housing 4110 includes a proximalcap 4112, a speaker protrusion 4147 (see e.g., FIGS. 8 and 9), and coverretention protrusions 4142 (see e.g., FIGS. 4 and 6). The speakerprotrusion 4147 is configured to maintain a position of an audio outputdevice 4956 of the electronic circuit system 4900 relative to thehousing 4110 when the electronic circuit system 4900 is attached to thehousing 4110, as described herein. Cover retention protrusions 4142 areconfigured to be received within corresponding openings 4215 on thecover 4200. In this manner, as described in more detail herein, thecover 4200 can be removably coupled to and disposed about at least aportion of the housing 4110.

As shown in FIG. 11, the proximal cap 4112 includes a gas containerretention member 4580 and defines a gas passageway 4144. The gascontainer retention member 4580 is configured to receive and/or retain agas container 4570 that can contain a pressurized gas. The gaspassageway 4144 is configured to allow for the passage of gas containedin the gas container 4570 from the gas cavity 4154 to the medicamentcavity 4157, as further described herein. Said another way, the gaspassageway 4144 places the gas cavity 4154 in fluid communication withthe medicament cavity 4157.

As shown in FIGS. 7 and 9, the distal end portion 4120 of the housing4110 defines a battery isolation protrusion aperture 4121, a needleaperture 4122, a safety lock actuator groove 4123, a safety lockaperture 4128, a base actuator groove 4124, base retention recesses4125A, 4125B, and base rail grooves 4127. The battery isolationprotrusion aperture 4121 is configured to receive the battery isolationprotrusion 4235 of the cover 4200 (see e.g., FIG. 25), as described infurther detail herein.

The needle aperture 4122 is configured to allow the needle 4512 (seee.g., FIG. 12) to exit the housing 4110 when the medical injector 4000is actuated. The portion of the sidewall of the housing 4110 thatdefines the needle aperture 4122 includes multiple sheath retentionprotrusions 4126. In some embodiments, the sheath retention protrusionscan interact with the a plurality of ribs 4728 of the needle sheath 4720(see e.g. FIG. 29) to maintain a position of the needle sheath 4720relative to the safety lock 4700 when the safety lock 4700 is coupled tothe housing 4110 and/or when the safety lock 4700 is being removed fromthe housing 4110.

The safety lock actuator groove 4123 is configured to receive anactuator 4744 of the safety lock 4700. As described in more detailherein, the actuator 4744 is configured to engage and/or activate theelectronic circuit system 4900 when the safety lock 4700 is moved withrespect to the housing 4110. The safety lock aperture 4128 is configuredto receive a safety lock protrusion 4742 (see e.g., FIGS. 25 and 26). Asdescribed in more detail below, the safety lock protrusion 4742 isreceived within an opening 4554 between extensions 4552 of a releasemember 4540 such that activation of the medical injector 4000 isprevented when the safety lock 4700 is in place. The safety lock 4700,its components and functions are further described herein.

The distal base retention recesses 4125A are configured to receive thebase connection knobs 4358 of the base 4300 (see e.g., FIG. 30) when thebase 4300 is in a first position relative to the housing 4110. Theproximal base retention recesses 4125B are configured to receive thebase connection knobs 4358 of the base 4300 when the base 4300 is in asecond position relative to the housing 4110. The base retentionrecesses 4125A, 4125B have a tapered proximal sidewall and a non-tapereddistal sidewall. This allows the base retention recesses 4125A, 4125B toreceive the base connection knobs 4358 such that the base 4300 can moveproximally relative to the housing 4110, but cannot move distallyrelative to the housing 4110. Said another way, the distal baseretention recesses 4125A are configured to prevent the base 4300 frommoving distally when the base 4300 is in a first position and theproximal base retention recesses 4125B are configured to prevent thebase 4300 from moving distally when the base 4300 is in a secondposition. Similarly stated, the proximal base retention recesses 4125Band the base connection knobs 4358 cooperatively prevent “kickback”after the medical injector 4000 is actuated.

The base actuator groove 4124 is configured to receive an actuator 4311of the base 4300. As described in more detail herein, the actuator 4311of the base 4300 is configured to engage the electronic circuit system4900 when the base 4100 is moved with respect to the housing 4110. Thebase rail grooves 4127 are configured to receive the guide members 4312of the base 4300. The guide members 4312 of the base 4300 and the baserail grooves 4127 of the housing 4110 engage each other in a way thatallows the guide members 4312 of the base 4300 to slide in a proximaland/or distal direction within the base rail grooves 4127 while limitinglateral movement of the guide members 4312. This arrangement allows thebase 4300 to move in a proximal and/or distal direction with respect tothe housing 4110 but prevents the base 4300 from moving in a lateraldirection with respect to the housing 4110.

FIG. 12 shows the medicament delivery mechanism 4500 of the medicalinjector 4000. The medical injector 4000 is similar to theauto-injectors described in U.S. patent application Ser. No. 11/562,061,entitled “Devices, Systems and Methods for Medicament Delivery,” filedNov. 21, 2006, which is incorporated herein by reference in itsentirety. Accordingly, only an overview of the medicament deliverymechanism 4500 and related operation of the medical injector 4000 isincluded below.

The medicament delivery mechanism 4500 includes a needle 4512, a carrier4520, a movable member 4530, a medicament container 4560, a gascontainer 4570, and a release member 4540. As described above, theneedle 4512, carrier 4520, movable member 4530 and medicament container4560 are disposed within the medicament cavity 4157 of the housing 4110.The gas container 4570 and the release member 4540 are disposed withinthe gas cavity 4154 of the housing 4110.

The release member 4540 has a proximal end portion 4542 and a distal endportion 4544, and is movably disposed within the distal end portion 4156of the gas cavity 4154. The proximal end portion 4542 of the releasemember 4540 includes a sealing member 4545 and a puncturer 4541. Thesealing member 4545 is configured to engage the sidewall of the housing4110 defining the gas cavity 4154 such that the proximal end portion4155 of the gas cavity 4154 is fluidically isolated from the distal endportion 4156 of the gas cavity 4154. In this manner, when gas isreleased from the gas container 4570, the gas contained in the proximalend portion 4155 of the gas cavity 4154 is unable to enter the distalend portion 4156 of the gas cavity 4154. The puncturer 4541 of theproximal end portion 4542 of the release member 4540 is configured tocontact and puncture a frangible seal 4573 on the gas container 4570when the release member 4540 moves proximally within the gas cavity4154, as shown by the arrow BB in FIG. 12.

The distal end portion 4544 of the release member 4540 includesextensions 4552. The extensions 4552 include projections 4547 thatinclude tapered surfaces 4549 and engagement surfaces 4548. Further, theextensions 4552 define an opening 4554 between the extensions 4552. Thetapered surfaces 4549 of the projections 4547 are configured to contactprotrusions 4313 on a proximal surface 4310 of the base 4300 (see e.g.,FIG. 30). The engagement surfaces 4548 of the projections 4547 areconfigured to extend through the safety lock aperture 4128 of thehousing 4110 and contact a distal surface of the housing 4110. In thismanner, the engagement surfaces 4548 of the projections 4547 limitproximal movement of the release member 4540 when the engagementsurfaces 4548 are in contact with the distal surface of the housing4110.

The opening 4554 defined by the extensions 4552 is configured to receivethe safety lock protrusion 4742 of the safety lock 4700 (see e.g., FIG.27). The safety lock protrusion 4742 is configured to prevent theextensions 4552 from moving closer to each other. Said another way, thesafety lock protrusion 4742 is configured to ensure that the extensions4552 remain apart and the engagement surfaces 4548 of the projections4547 remain in contact with the distal end portion 4120 of the housing4110. In some embodiments, for example, the release member 4540 and/orthe extensions 4552 can be constructed from any suitable materialconfigured to withstand deformation that may occur when exposed to aload over an extended period of time. In some embodiments, for example,the release member 4540 and/or the extensions 4552 can be constructedfrom brass.

The gas container 4570 includes a distal end portion 4572 and a proximalend portion 4576, and is configured to contain a pressurized gas. Thedistal end portion 4572 of the gas container 4570 contains a frangibleseal 4573 configured to break when the puncturer 4541 of the proximalend portion 4542 of the release member 4540 contacts the frangible seal4573. The gas container retention member 4580 of the proximal cap 4112of the housing 4110 is configured to receive and/or retain the proximalend portion 4576 of the gas container 4570. Said another way, theposition of the gas container 4570 within the gas cavity 4154 ismaintained by the gas container retention member 4580.

The medicament container 4560 of the medicament delivery mechanism 4500has a distal end portion 4562 and a proximal end portion 4566, and isconfigured to contain a medicament. The distal end portion 4562 of themedicament container 4560 contains a seal 4523. The seal 4523 isconfigured to burst when punctured by the proximal end 4516 of theneedle 4512, as described below. The proximal end portion 4566 of themedicament container 4560 is configured to receive a piston portion 4534of the movable member 4530.

The movable member 4530 of the medicament delivery mechanism 4500 ismovably disposed within the medicament cavity 4157. The movable member4530 includes a piston portion 4534 having a plunger at the distal endportion of the piston portion 4534. The piston portion 4534 isconfigured to move within the medicament container 4560. In this manner,the piston portion 4534 of the movable member 4530 can apply pressure toa medicament contained in the medicament container 4560. The pistonportion 4534 can be constructed of a resilient, durable, and/or sealingmaterial, such as a rubber.

The carrier 4520 of the medicament delivery mechanism 4500 includes adistal end portion 4522 and a proximal end portion 4526. The medicamentcontainer 4560 is coupled to the carrier 4520 via a “snap-fit”connection (not shown) such that the medicament container 4560 can moverelative to the carrier 4520 between a first configuration and a secondconfiguration during an injection event. In the first configuration, thecarrier 4520 is configured to move within the medicament cavity 4157such that movement of the carrier 4520 within the medicament cavity 4157causes contemporaneous movement of the medicament container 4560 withinthe medicament cavity 4157. The proximal end portion 4516 of the needle4512 is spaced apart from the seal 4523 of the medicament container 4560when the carrier 4520 is in the first configuration. In the secondconfiguration, the medicament container 4560 releases from the“snap-fit” causing the medicament container 4560 to move distally withrespect to the carrier 4520, causing the proximal end portion 4516 ofthe needle 4512 to pierce the seal 4523. In this manner, the needle 4512can be selectively placed in fluid communication with the medicamentcontainer 4560 to define a medicament delivery path (not shown).

FIGS. 13-22 show the electronic circuit system 4900. The electroniccircuit system 4900 of the medical injector 4000 includes an electroniccircuit system housing 4170, a printed circuit board 4922, a batteryassembly 4962, an audio output device 4956, two light emitting diodes(LEDs) 4958A, 4958B and a battery clip 4910. As shown in FIG. 20, theelectronic circuit system 4900 is configured to fit within theelectronic circuit system cavity 4153 of the housing 4110. Accordingly,as described above, the electronic circuit system 4900 is physicallyand/or fluidically isolated from the medicament cavity 4157, the gascavity 4154 and/or the medicament delivery device 4500. As describedherein, the electronic circuit system 4900 is configured to output anelectronic output associated with the use of the medical injector 4000.

The electronic circuit system housing 4170 of the electronic circuitsystem 4900 includes a distal end portion 4180 and a proximal endportion 4190. The proximal end portion 4190 includes connectionprotrusions 4171A and a battery clip protrusion 4173. The connectionprotrusions 4171A extend from the proximal end portion 4190 of theelectronic circuit system housing 4170, and are configured to bedisposed within the connection apertures 4152 of the housing 4110, asdescribed above. In this manner, the electronic circuit system 4900 canbe coupled to the housing 4110 within the electronic circuit systemcavity 4153. In other embodiments, the electronic circuit system 4900can be coupled to the housing 4110 by other suitable means such as anadhesive, a clip and/or the like. As described in more detail herein,the battery clip protrusion 4173 is configured to hold the battery clip4910 in place.

The proximal end portion 4190 of the electronic circuit system housing4170 defines multiple sound apertures 4191. The audible output device4956 is disposed against the proximal end portion 4190 of the electroniccircuit system housing 4170 such that the front face of the audibleoutput device 4956 is disposed adjacent the sound apertures 4191. Inthis manner, the sound apertures 4191 are configured to allow sound froman audio output device 4956 to pass from the audio output device 4956 toa region outside of the housing 4110.

As shown in FIGS. 16 and 17, the distal end portion 4180 of theelectronic circuit system housing 4170 includes a connection protrusion4171B, a stiffening protrusion 4174, and defines an LED aperture 4181,an aperture 4172, a safety lock actuator groove 4182, and a baseactuator groove 4183. The LED aperture 4181 is configured to receive theLEDs 4958A, 4958B such that a user can view the LEDs 4958A, 4958B, whichare described in more detail herein.

The connection protrusion 4171B extends from the distal end portion 4180of the electronic circuit system housing 4170, and is configured toattach the electronic circuit system 4900 to the housing 4110, asdescribed above. The stiffening protrusion 4174 is configured to have atleast a portion received within and/or accessible via the aperture 4145in the housing 4110 (see e.g., FIG. 6). The stiffening protrusion 4174is configured to limit the bending (e.g., buckling) of the electroniccircuit system housing 4170 when the electronic circuit system housing4170 is coupled to the housing 4110. Moreover, a user can access thestiffening protrusion 4174 via the aperture 4172. In this manner, forexample, the user can disengage the stiffening protrusion 4174 from theaperture 4145.

The safety lock actuator groove 4182 of the electronic circuit systemhousing 4170 is configured to be disposed adjacent the safety lockactuator groove 4123 of the distal end portion 4120 of the housing 4110.In this manner, the safety lock actuator groove 4182 of the electroniccircuit system housing 4170 and the safety lock actuator groove 4123 ofthe distal end portion 4120 of the housing 4110 collectively receive theactuator 4744 of the safety lock 4700, which is described in more detailherein. Similarly, the base actuator groove 4183 of the electroniccircuit system housing 4170 is configured to be disposed about the baseactuator groove 4124 of the distal end portion 4120 of the housing 4110.The base actuator groove 4183 of the electronic circuit system housing4170 and the base actuator groove 4124 of the distal end portion 4120 ofthe housing 4110 collectively receive the actuator 4311 of the base4300, which is described in more detail herein.

The printed circuit board 4922 of the electronic circuit system 4900includes a substrate 4924, a first actuation portion 4926 and a secondactuation portion 4946. The substrate 4924 of the printed circuit board4922 includes the electrical components necessary for the electroniccircuit system 4900 to operate as desired. For example, the electricalcomponents can be resistors, capacitors, inductors, switches,microcontrollers, microprocessors and/or the like.

As shown in FIGS. 21-23, the first actuation portion 4926 includes afirst electrical conductor 4934 and defines an opening 4928 having aboundary 4929. The opening 4928 of the first actuation portion 4926 isconfigured to receive a protrusion 4746 of the actuator 4744 of thesafety lock 4700. The boundary 4929 of the first opening 4928 has adiscontinuous shape, such as, for example, a teardrop shape, thatincludes a stress concentration riser 4927. The discontinuity and/or thestress concentration riser 4927 of the boundary 4929 can be of anysuitable shape to cause the substrate 4924 to deform in a predetermineddirection when the protrusion 4746 of the actuator 4744 of the safetylock 4700 is moved relative to the opening 4928, as shown by the arrowCC in FIG. 22.

The opening 4928 is defined adjacent the first electrical conductor 4934that electronically couples the components included in the electroniccircuit system 4900. The first electrical conductor 4934 includes afirst switch 4972, which can be, for example a frangible portion of thefirst electrical conductor 4934. In use, when the safety lock 4700 ismoved from a first position (see e.g., FIG. 21) to a second position(see e.g., FIG. 22), the actuator 4744 moves in a directionsubstantially parallel to a plane defined by a surface of the firstactuation portion 4926 of the substrate 4924. The movement of theactuator 4744 causes the protrusion 4746 to move within the firstopening 4928, as indicated by the arrow CC in FIG. 22. The movement ofthe protrusion 4746 tears the first actuation portion 4926 of thesubstrate 4924, thereby separating the portion of the first electricalconductor 4934 including the first switch 4972. Said another way, whenthe safety lock 4700 is moved from its first position to its secondposition (see e.g., FIG. 33), the actuator 4744 moves irreversibly thefirst switch 4972 from a first state (e.g., a state of electricalcontinuity) to a second state (e.g., a state of electricaldiscontinuity). Said yet another way, when the safety lock 4700 is movedfrom its first position to its second position, the actuator 4744disrupts the first electrical conductor 4934.

The second actuation portion 4946 includes a second electrical conductor4935 and defines an opening 4945, having a boundary 4949 and a tearpropagation limit aperture 4948. As shown in FIGS. 20-23, the opening4945 of the second actuation portion 4946 is configured to receive aportion of an actuator 4311 of the base 4300. The boundary 4949 of theopening 4945 has a discontinuous shape that includes a stressconcentration riser 4947. The discontinuity and/or the stressconcentration riser 4947 of the boundary 4949 can be of any suitableshape to cause the substrate 4924 to deform in a predetermined directionwhen the actuator 4311 of the base 4300 is moved in a proximal directionrelative to the opening 4945, as shown by the arrow DD in FIG. 23.

The second electrical conductor 4935 includes a second switch 4973disposed between the opening 4945 and the tear propagation limitaperture 4948, which can be, for example, a frangible portion of thesecond electrical conductor 4935. In use, when the base 4300 is movedfrom its first position to its second position (see e.g., FIG. 34), theactuator 4311 moves in a proximal direction, substantially parallel to aplane defined by a surface of the second actuation portion 4946 of thesubstrate 4924. The proximal movement of the actuator 4311 tears thesecond actuation portion 4946 of the substrate 4924, thereby separatingthe portion of the second electrical conductor 4935 including the secondswitch 4973. Said another way, when the base 4300 is moved from itsfirst position to its second position, the actuator 4311 movesirreversibly the second switch 4973 from a first state (e.g., a state ofelectrical continuity) to a second state (e.g., a state of electricaldiscontinuity). The tear propagation limit aperture 4948 is configuredto limit the propagation of the tear in the substrate 4924 in theproximal direction. Said another way, the tear propagation limitaperture 4948 is configured to ensure that the tear in the substrate4924 does not extend beyond the tear propagation limit aperture 4948.The tear propagation limit aperture 4948 can be any shape configured tostop the propagation of a tear and/or disruption of the substrate 4924.For example, the tear propagation limit aperture 4948 can be ovalshaped. In other embodiments, the proximal boundary of the tearpropagation limit aperture 4948 can be reinforced to ensure that thetear in the substrate 4924 does not extend beyond the tear propagationlimit aperture 4948.

The battery assembly 4962 of the electronic circuit system 4900comprises two batteries stacked on top of one another. The batteryassembly 4962 has a first surface 4964 and a second surface 4966. Thefirst surface 4964 of the battery assembly 4962 can contact anelectrical contact (not shown) disposed on the substrate 4924. Thesecond surface 4966 of the battery assembly 4962 is configured tocontact a contact portion 4918 of a distal end portion 4916 of a batteryclip 4910. When both the electrical contact of the substrate 4924 andthe contact portion 4918 of the distal end portion 4916 of the batteryclip 4910 contact the battery assembly 4962, the batteries of thebattery assembly 4962 are placed in electrical communication with theelectronic circuit system 4900. Said another way, when the electricalcontact of the substrate 4924 and the contact portion 4918 of the distalend portion 4916 of the battery clip 4910 contact the battery assembly4962, the battery assembly 4962 is configured to supply power to theelectronic circuit system 4900.

The battery clip 4910 (shown in FIG. 18) includes a proximal end portion4912 and a distal end portion 4916. The proximal end portion 4912defines a retention aperture 4913. The retention aperture 4913 isconfigured to receive the battery clip protrusion 4173 of the electroniccircuit system housing 4170. In this manner, the battery clip protrusion4173 maintains the position of the battery clip 4910 with respect to theelectronic circuit system housing 4170 and/or the battery assembly 4962.

The distal end portion 4916 of the battery clip 4910 includes a contactportion 4918 and an angled portion 4917. As described above, the contactportion 4918 is configured to contact the second surface 4916 of thebattery assembly 4962 to place the battery assembly 4962 in electricalcommunication with the electronic circuit system 4900. The angledportion 4917 of the distal end portion 4916 of the battery clip 4910 isconfigured to allow a proximal end portion 4236 of a battery isolationprotrusion 4235 (see e.g., FIG. 25) to be disposed between the secondsurface 4966 of the battery assembly 4962 and the contact portion 4918of the distal end portion 4916 of the battery clip 4910. When thebattery isolation protrusion 4235 is disposed between the second surface4966 of the battery assembly 4962 and the contact portion 4918 of thedistal end portion 4916 of the battery clip 4910, the electrical pathbetween the battery assembly 4962 and the remainder of the electricalcircuit system 4900 is severed, thereby removing power from theelectronic circuit system 4900. The contact portion 4918 of the distalend portion 4916 of the battery clip 4910 is biased such that when thebattery isolation protrusion 4235 is removed, the contact portion 4918will move into contact the second surface 4916 of the battery assembly4962, thereby restoring electrical communication between the batteryassembly 4962 and the electronic circuit system 4900. In someembodiments, the battery isolation protrusion 4235 can be repeatedlyremoved from between the second surface 4966 of the battery assembly4962 and the contact portion 4918 of the distal end portion 4916 of thebattery clip 4910 and reinserted. Said another way, the batteryisolation protrusion 4235 and the battery clip 4910 collectively form areversible on/off switch.

The audio output device 4956 of the electronic circuit system 4900 isconfigured to output audible sound to a user in response to a use of themedical injector 4000. In some embodiments, the audible output device4956 can be a speaker. In some embodiments, the audible sound can be,for example, associated with a recorded message and/or a recordedspeech. In other embodiments, the audible instructions can be an audiblebeep, a series of tones and/or or the like.

In other embodiments, the medical injector 4000 can have a networkinterface device (not shown) configured to operatively connect theelectronic circuit system 4900 to a remote device (not shown) and/or acommunications network (not shown). In this manner, the electroniccircuit system 4900 can send information to and/or receive informationfrom the remote device. The remote device can be, for example, a remotecommunications network, a computer, a compliance monitoring device, acell phone, a personal digital assistant (PDA) or the like. Such anarrangement can be used, for example, to download replacementprocessor-readable code from a central network to the electronic circuitsystem 4900. In some embodiments, for example, the electronic circuitsystem 4900 can download information associated with a medical injector4000, such as an expiration date, a recall notice, updated useinstructions or the like. Similarly, in some embodiments, the electroniccircuit system 4900 can upload compliance information associated withthe use of the medical injector 4000 via the network interface device.

FIGS. 24 and 25 show the cover 4200 of the medical injector 4000. Thecover 4200 includes a proximal end portion 4210 and a distal end portion4230, and defines a cavity 4242. The cavity 4242 of the cover 4200 isconfigured to receive at least a portion of the housing 4110. Theproximal end portion 4210 defines apertures 4215 configured to receivethe cover retention protrusions 4142 of the housing 4110 (shown in FIGS.4 and 6). In this manner, the apertures 4215 and the cover retentionprotrusions 4142 of the housing 4110 removably retain the cover 4200about at least a portion of the housing 4110. Said another way, theapertures 4215 and the cover retention protrusions 4142 of the housing4110 are configured such that the cover 4200 can be removed from aportion of the housing 4110 and then replaced about the portion of thehousing 4110.

The distal end portion 4230 of the cover 4200 includes a batteryisolation protrusion 4235. The battery isolation protrusion 4235includes a proximal end portion 4236 and a tapered portion 4237. Theproximal end portion 4236 of the battery isolation protrusion 4235 isconfigured to be removably disposed between the second surface 4966 ofthe battery assembly 4962 and the contact portion 4918 of the distal endportion 4916 of the battery clip 4910, as described above.

FIGS. 26-29 show the safety lock 4700 of the medical injector 4000. Thesafety lock 4700 of the medical injector 4000 includes a proximalsurface 4740, a distal surface 4760 opposite the proximal surface 4740and a needle sheath 4720. The safety lock 4700 defines a needle sheathaperture 4770 and a battery isolation protrusion aperture 4775. Thebattery isolation protrusion aperture 4775 is configured to receive thebattery isolation protrusion 4235 of the cover 4200 such that thebattery isolation protrusion 4235 can be disposed within the electroniccircuit system cavity 4153 or the electronic circuit system 4900, asdescribed above. Similarly stated, the battery isolation protrusionaperture 4775 of the safety lock 4700 is aligned with the batteryisolation protrusion aperture 4121 of the housing 4110, such that thebattery isolation protrusion 4235 can be disposed within the electroniccircuit system cavity 4153 when the cover 4200 is disposed about aportion of the housing 4110.

The proximal surface 4740 of the safety lock 4700 includes a safety lockprotrusion 4742, a stopper 4743, an actuator 4744 and two opposing pulltabs 4741. As described above, when the safety lock 4700 is in a first(locked) position, the safety lock protrusion 4742 is configured to bedisposed in the opening 4554 defined by the extensions 4552 of thedistal end portion 4544 of the release member 4540. Accordingly, thesafety lock protrusion 4742 is configured to prevent the extensions 4552from moving closer to each other, thereby preventing proximal movementof the release member 4540 of the medicament delivery mechanism 4500and/or delivery of a medicament. The stopper 4743 of the safety lock4700 is a protrusion extending from the proximal surface 4740 of thesafety lock 4700. The stopper 4743 is configured to contact a portion ofthe housing 4110 to limit the proximal movement of the safety lock 4700relative to the housing 4110. In other embodiments, the stopper 4743 canbe any structure configured to limit the proximal movement of the safetylock 4700.

The actuator 4744 of the safety lock 4700 has an elongated portion 4745and a protrusion 4746. The elongated portion 4745 extends in a proximaldirection from the proximal surface 4740. In this manner, the elongatedportion 4745 can extend through a safety lock actuator opening 4356 ofthe base 4300 (see e.g., FIG. 30) and within the safety lock actuatorgroove 4123 of the housing 4110 and the safety lock actuator groove 4182of the electronic circuit system housing 4170. The protrusion 4746extends in a direction substantially transverse to the elongated portion4745 and/or substantially parallel to the proximal surface 4740 of thesafety lock 4700. As described above, the opening 4928 of the firstactuation portion 4926 is configured to receive the protrusion 4746 ofthe actuator 4744 of the safety lock 4700.

The pull tabs 4741 of the safety lock 4700 include a grip portion 4747and indicia 4748. The grip portion 4747 of the pull tabs 4741 providesan area for the user to grip and/or remove the safety lock 4700 from therest of the medicament delivery system 4700. The indicia 4748 providesinstruction on how to remove the safety lock 4700. In some embodiments,for example, the indicia 4748 can indicate the direction the user shouldpull the safety lock 4700 to remove the safety lock 4700.

As shown in FIG. 28, the needle sheath 4720 of the safety lock 4700includes a distal end portion 4724, a proximal end portion 4722 and aplurality of ribs 4728. The needle sheath 4720 can also define a lumen4729. The lumen 4729 of the safety lock 4700 is configured to receivethe needle 4512. In this manner, the needle sheath 4720 can protect theuser from the needle 4512 and/or can keep the needle 4512 sterile beforethe user uses the medical injector 4000. The proximal end portion 4722of the needle sheath is configured to contact the distal end portion4522 of the carrier 4520 of the medicament delivery mechanism 4500.

The distal end portion 4724 of the needle sheath 4720 has an angledridge 4725. The angled ridge 4725 is configured to allow the proximalend portion 4722 of the needle sheath 4720 to irreversibly move throughthe needle sheath aperture 4770 of the safety lock 4700 in a distaldirection. Said another way, the angled ridge 4725 can be configured insuch a way as to allow the proximal end portion 4722 of the needlesheath 4720 to move through the needle sheath aperture 4770 in a distaldirection, but not in a proximal direction. The needle sheath aperture4770 has retaining tabs 4771 configured to engage the proximal end ofthe angled ridge 4725 when the needle sheath 4720 is moved in a proximaldirection. In this manner, the retaining tabs 4771 prevent the proximalmovement of the needle sheath with respect to the safety lock 4700.Further, the retaining tabs 4771 are configured to engage the proximalend of the angled ridge 4725 when the safety lock 4700 is moved in adistal direction. Said another way, as shown in FIG. 33, the needlesheath 4720 is removed from the needle 4512 when the safety lock 4700 ismoved in a distal direction with respect to the housing 4110.

FIGS. 30-31 show the base 4300 of the medical injector 4000. The base4300 includes a proximal surface 4310, a distal surface 4330 and baseconnection knobs 4358. The base 4300 defines a needle aperture 4350, asafety lock protrusion aperture 4352, a battery isolation protrusionaperture 4354, a safety lock actuator opening 4356, and pull tabopenings 4360. The needle aperture 4350 is configured to receive theneedle 4512 when the medical injector 4000 is actuated. The safety lockprotrusion aperture 4352 of the base 4300 receives the safety lockprotrusion 4742 of the safety lock 4700. The battery isolationprotrusion aperture 4354 of the base 4300 receives the battery isolationprotrusion 4235 of the cover 4200 and the stopper 4743 of the safetylock 4700. The safety lock actuator opening 4356 receives the safetylock actuator 4744 of the safety lock 4700. The pull tab openings 4360are configured to receive the pull tabs 4741 of the safety lock 4700.

The proximal surface 4310 of the base 4300 includes an actuator 4311,guide members 4312, and protrusions 4313. The actuator 4311 is anelongate member configured to engage the substrate 4924 of theelectronic circuit system 4900. As described above, the opening 4945 ofthe second actuation portion 4946 is configured to receive the actuator4311 of the base 4300. The guide members 4312 of the base 4300 areconfigured to engage and/or slide within the base rail grooves 4127 ofthe housing 4110, as described above. The protrusions 4313 of the base4300 are configured to engage the tapered surfaces 4549 of theextensions 4552 of the release member 4540. As described in furtherdetail herein, when the safety lock 4700 is removed and the base 4300 ismoved in a proximal direction with respect to the housing 4110, theprotrusion 4313 of the base 4300 are configured to move the extensions4552 of the release member 4540 closer to each other, actuating themedicament delivery mechanism 4500. As described above, the baseconnection knobs 4358 are configured to engage the base retentionrecesses 4125A, 4125B in a way that allows proximal movement of the base4300 but limits distal movement of the base 4300.

As shown in FIG. 32, the medical injector 4000 is first enabled bymoving the medicament delivery device from a first configuration to asecond configuration by moving the cover 4200 from a first position to asecond position. The cover 4200 is moved from the first position to thesecond position by moving it with respect to the housing 4110 in thedirection shown by the arrow EE in FIG. 32. When the cover 4200 is movedwith respect to the housing 4110 in the direction EE, the batteryisolation protrusion 4235 is removed from the area between the batteryclip 4910 and the second surface 4966 of the battery assembly 4962. Inthis manner, the battery assembly 4962 can be operatively coupled to theelectronic circuit system 4900 when the cover 4200 is removed, therebyproviding power to the electronic circuit system 4900.

When power is provided, as described above, the electronic circuitsystem 4900 can output one or more predetermined electronic outputs. Forexample, in some embodiments, the electronic circuit system 4900 canoutput an electronic signal associated with recorded speech to theaudible output device 4956. Such an electronic signal can be, forexample, associated with a .WAV file that contains a recordedinstruction instructing the user in the operation of the medicalinjector 4000. Such an instruction can state, for example, “remove thesafety tab near the base of the auto-injector.” The electronic circuitsystem 4900 can simultaneously output an electronic signal to one and/orboth of the LEDs 4958A, 4958B thereby causing one and/or both of theLEDs 4958A, 4958B to flash a particular color. In this manner, theelectronic circuit system 4900 can provide both audible and visualinstructions to assist the user in the initial operation of the medicalinjector 4000.

In other embodiments, the electronic circuit system 4900 can output anelectronic output associated with a description and/or status of themedical injector 4000 and/or the medicament contained therein. Forexample, in some embodiments, the electronic circuit system 4900 canoutput an audible message indicating the type of medicament contained inthe medical injector 4000, the expiration date of the medicament, thedosage of the medicament or the like.

As described above, the medical injector 4000 can be can be repeatedlymoved between the first configuration and the second configuration whenthe cover 4200 is moved repeatedly between the first position and thesecond position respectively. Said another way, the cover 4200 can beremoved and replaced about the housing 4110 any number of times. Whenthe cover 4200 is moved from the second position to the first position,the battery isolation protrusion 4235 is inserted between the batteryclip 4910 and the second surface 4966 of the battery assembly 4962,deactivating the electronic circuit system 4900. When the cover is movedfrom the first position to the second position a second time, theelectronic circuit system 4900 is once again activated. In this manner,the cover 4200 can be removed and the electronic circuit system 4900 canoutput an electronic output without compromising the sterility of theneedle 4512.

After the cover 4200 is removed from the housing 4110, the medicalinjector 4000 can be moved from the second configuration to a thirdconfiguration by moving the safety lock 4700 from a first position to asecond position. The safety lock 4700 is moved from a first position toa second position by moving the safety lock 4700 with respect to thehousing 4110 in the direction shown by the arrow FF in FIG. 33. When thesafety lock 4700 is moved from the first position to the secondposition, the safety lock protrusion 4742 is removed from between theextensions 4552 of the release member 4540, thereby enabling themedicament delivery member 4500. Moreover, as shown in FIGS. 21 and 22,when the safety lock 4700 is moved from the housing 4110, the actuator4744 of the safety lock 4700 moves in the direction CC as shown in FIG.22, irreversibly moving the first switch 4972 from a first state (e.g.,a state of electrical continuity) to a second state (e.g., a state ofelectrical discontinuity). When the actuator 4744 of the safety lock4700 moves irreversibly the first switch 4972 of the electronic circuitsystem 4900 to the second state, the electronic circuit system 4900 canoutput one or more predetermined electronic outputs. For example, insome embodiments, a processor (not shown) can output an electronicsignal associated with recorded speech to the audible output device4956. Such an electronic signal can be, for example, associated with arecorded message notifying the user of the status of the medicalinjector 4000. Such a status message can state, for example, “Themedical injector is now enabled.” The electronic circuit system 4900 canalso simultaneously output an electronic signal to one and/or both ofthe LEDs 4958A, 4958B, thereby causing one and/or both of the LEDs4958A, 4958B to stop flashing, change color or the like.

In some embodiments, the first actuation portion 4926 and the actuator4744 can be configured such that the actuator 4744 must move apredetermined distance before the actuator 4744 engages the boundary4929 of the opening 4928. For example, in some embodiments, the actuator4744 must move approximately 0.200 inches before the actuator 4744engages the boundary 4929 of the opening 4928. In this manner, thesafety lock 4700 can be moved slightly without irreversibly moving thefirst switch 4972 of the electronic circuit system 4900 to the secondstate. Accordingly, this arrangement will permit the user toinadvertently and/or accidentally move the safety lock 4700 withoutactuating the electronic circuit system 4900.

In some embodiments, the electronic circuit system 4900 can beconfigured to output the status message for a predetermined time period,such as, for example, five seconds. After the predetermined time periodhas elapsed, the electronic circuit system 4900 can output an audiblemessage further instructing the user in the operation of the medicalinjector 4000. Such an instruction can state, for example, “Place thebase of the auto-injector against the patient's thigh. To complete theinjection, press the base firmly against the patient's thigh.” In someembodiments, the electronic circuit system 4900 can simultaneouslyoutput an electronic signal to one and/or both of the LEDs 4958A, 4958B,thereby causing one and/or both of the LEDs 4958A, 4958B to flash aparticular color. In this manner, the electronic circuit system 4900 canprovide both audible and/or visual instructions to assist the user inthe placement and actuation of the medical injector 4000. In someembodiments, the electronic circuit system 4900 can be configured torepeat the instructions after a predetermined time period has elapsed.

As described above, in other embodiments, the medical injector 4000 canhave a network interface device (not shown) configured to operativelyconnect the electronic circuit system 4900 to a remote device (notshown) and/or a communications network (not shown). In this manner, theelectronic circuit system 4900 can send a wireless signal notifying aremote device that the safety lock 4700 of the medical injector 4000 hasbeen removed and that the medical injector 4000 has been armed.

After the safety lock 4700 is moved from the first position to thesecond position, the medical injector 4000 can be moved from the thirdconfiguration to a fourth configuration by moving the base 4300 from afirst position to a second position. The base 4300 is moved from itsfirst position to its second position by placing the medical injector4000 against the body of the patient and moving the base 4300 withrespect to the housing 4110 in the direction shown by the arrow GG inFIG. 34. Moving the base 4300 from the first position to the secondposition causes the protrusions 4313 on the proximal surface 4310 of thebase 4300 to engage the tapered surfaces 4549 of the extensions 4552 ofthe release member 4540, causing the release member 4540 to actuate themedicament delivery mechanism 4500 and deliver a medicament to a body ofa patient.

When the base 4300 is moved from the first position to the secondposition, the medicament delivery mechanism 4500 is actuated such thatthe puncturer 4541 of the release member 4540 is brought in contact withand/or punctures the frangible seal 4573 of the gas container 4570. Insome embodiments, the movement of the release member 4540 can be causedby a spring (not shown in FIG. 12). After the frangible seal 4573 hasbeen punctured, an actuating portion of a compressed gas can escape fromthe gas container 4570 and flow via the gas passageway 4144 into themedicament cavity 4157. The gas applies gas pressure to the movablemember 4530 causing the movable member 4530 and the carrier 4520 to movein a distal direction within the medicament cavity 4157. When thecarrier 4520 moves distally within the medicament cavity 4157, thecarrier 4520 and the medicament container 4560 are in a firstconfiguration. Accordingly, as described above, the medicament container4560 is connected to the carrier 4520 by a “snap fit” connection. Inthis manner, the medicament container 4560 and the needle 4512contemporaneously move with movable member 4530 and/or the carrier 4520in a distal direction. As described above, the proximal end portion 4516of the needle 4512 is connected to the distal end portion 4522 of thecarrier 4520 and is spaced from the seal 4523 of the medicamentcontainer 4560 when the carrier 4520 is in its first configuration. Saidanother way, the medicament container 4560 and the needle 4512 do notdefine a medicament delivery path when the carrier 4520 is in the firstconfiguration. The movement of the needle 4512 in a distal directioncauses the proximal end portion 4516 of the needle 4512 to exit thehousing 4110 and enter the body of a patient prior to administering amedicament.

After the carrier 4520 and/or the needle 4512 have moved within themedicament cavity 4157 a predetermined distance, the carrier 4520 andthe medicament container 4560 are moved from the first configuration toa second configuration. In the second configuration of the carrier 4520,the medicament container 4560 is released from the “snap-fit” allowingthe medicament container 4560 and the movable member 4530 to continue tomove in a distal direction relative to the carrier 4520. Said anotherway, the medicament container 4560 is configured to slidably move withinthe carrier 4520 when the carrier is moved from the first configurationto the second configuration. As the medicament container 4560 continuesto move within the carrier 4520, the proximal end portion 4516 of theneedle 4512 contacts and punctures the seal 4523 of the medicamentcontainer 4560. This allows the medicament contained in the medicamentcontainer 4560 to flow into the lumen (not shown) defined by the needle4512, thereby defining a medicament delivery path.

As the medicament container 4560 contacts the distal end of the carrier4520, the medicament container 4560 stops moving within the carrier 4520while the movable member 4530 continues to move in a distal direction.This causes the piston portion 4534 of the movable member 4530 tosealingly slide and/or move within the medicament container 4560containing a liquid medicament. As the piston portion 4534 of themovable member 4530 sealingly slides and/or moves within the medicamentcontainer 4560, the piston portion 4534 generates a pressure upon themedicament contained within the medicament container 4560, therebyallowing at least a portion of the medicament to flow out of themedicament container 4560 and into the lumen defined by the needle 4512.The medicament is delivered to a body of a user via the medicamentdelivery path defined by the medicament container 4560 and the needle4512.

As described above, the actuator 4538 of the base 4300 actuates theelectronic circuit 4900 to trigger a predetermined output or sequence ofoutputs when the base 4520 is moved from its first position to itssecond position (see, e.g., FIGS. 19-23). When the actuator 4538 ismoved in a proximal direction relative to the opening 4945, as shown bythe arrow DD in FIG. 23, the electronic circuit system 4900 is actuatedto output one or more predetermined electronic outputs. For example, insome embodiments, the electronic circuit system 4900 can output anelectronic signal associated with recorded speech to the audible outputdevice 4956. Such an electronic signal can be, for example, associatedwith an audible countdown timer, instructing the user on the duration ofthe injection procedure. Said another way, if it takes, for example, tenseconds to complete an injection, an audible countdown timer can countfrom ten to zero ensuring that the user maintains the medical injector4000 in place for the full ten seconds. In other embodiments, theelectronic signal can be, for example, associated with a recordedmessage notifying the user that the injection is complete, instructingthe user on post-injection disposal and safety procedures, instructingthe user on post-injection medical treatment or the like. Such a statusmessage can state, for example, “The injection is now complete. Pleaseseek further medical attention from a doctor.” The electronic circuitsystem 4900 can also simultaneously output an electronic signal to oneand/or both LEDs 4958A, 4958B, thereby causing one and/or both LEDs4958A, 4958B to stop flashing, change color or the like, to provide avisual indication that the injection is complete. In other embodiments,the electronic circuit system 4900 can send a wireless signal notifyinga remote device that the injection is complete. In this manner, apatient's compliance can be monitored.

In some embodiments, the second actuation portion 4946 and the actuator4538 can be configured such that the base 4500 and/or the actuator 4538must move a predetermined distance before the actuator 4538 engages theboundary 4949 of the opening 4945. For example, in some embodiments, theactuator 4538 must move approximately 0.200 inches before the actuator4538 engages the boundary 4949 of the opening 4945. In this manner, thebase 4700 can be moved slightly without irreversibly moving the secondswitch 4973 of the electronic circuit system 4900 to the second state.Accordingly, this arrangement will permit the user to inadvertentlyand/or accidentally move the base 4500 without actuating the electroniccircuit system 4900.

FIG. 35 depicts a medicament delivery device 100 (e.g., any suitabledevice, such as the medicament injectors described above with referenceto FIGS. 1-35), an adapter 120 and a locator 150. The medicamentdelivery device 100 can be paired with and/or cooperatively functionwith the adapter 120 and/or the locator 150 to “page,” locate and/orotherwise assist a patient and/or third party in determining theidentity and/or location of the medicament delivery device 100. Thelocator 150 can be any suitable device that is operable to send a signalto the adapter 120 causing the adapter 120 to emit a sound or othersignal. In this manner, the monitoring 150 device and the adapter 120can cooperatively function to alert the user to the location of themedicament delivery device 100.

The adapter 120 can be coupled to the medicament delivery device 100.The adapter 120 can, for example, be a sleeve, case, insert, attachment,and/or docking station coupled to the medicament delivery device 100, ahousing of the medicament delivery device 100 (such as the housing 4100described above) and/or electronic circuitry of the medicament deliverydevice 100. In some embodiments, the adapter 120 can be removablycoupled to and substantially surround a portion of the medicamentdelivery device 100, similar to the cover 4200 shown and describedabove. In other embodiments, an adapter 120 can be attached to an outersurface of a medicament delivery device 100 without surrounding orcovering a significant portion of the medicament delivery device. In yetother embodiments, an adapter 120 can be inserted completely orpartially into an inside chamber of a medicament delivery device. In yetother embodiments, an adapter 120 can be fixedly coupled to an outersurface of a medicament delivery device. Although shown as being aseparate component, in some embodiments, an adapter 120 can be integralwith the medicament delivery device 100. Said another, in someembodiments, the function of the adapter 120 described below can beincluded within a housing and/or electronic circuit system of themedicament delivery device 100.

The adapter 120 can include a radio 122 (also referred to as a receiver,transmitter and/or transceiver) and/or an audible output device 124. Theradio 122 of the adapter 120 can be operable to send signals to, and/orreceive signals from the locator 150. The audible output device 124 ofthe locator device can be operable to emit an audible output, such as atone and/or recorded speech instructions. As discussed in further detailherein, in some embodiments, the adapter 120 can include a sensor (orswitch) 126 operable to detect an event associated with the medicamentdelivery device 100. Such events can include, for example, when themedicament delivery device 100 is used and/or is prepared for use. Inthis manner, the sensor 126 can detect the status and/or usage historyof the medicament delivery device 100. For example, in some embodiments,the adapter 120 can be a sleeve or cover (similar to the cover 4200shown and described above) that is removed from the medicament deliverydevice 100 prior to use. In such embodiments, the sensor and/or switch126 can be operable to detect the removal the adapter 120 from themedicament delivery device 100 and can cause the adapter 120 to send asignal (e.g., to the locator 150) via the radio 122 and/or to emit anaudible output via the audible output device 124.

Although described as producing an audible output, in other embodiments,any of the devices and/or systems described herein can produce a humanperceivable signal, such as audible, visual, and/or haptic alerts. Inother embodiments, the signal can be a radio signal, IR signal and/orsignals otherwise not human perceivable. An embodiment can include bothhuman perceivable and signals that are not human perceivable.

In some embodiments, the adapter 120 can include an electronic circuitsystem, similar to the electronic circuit system 4900 shown anddescribed above, to contain, include and/or provide interconnectionbetween the components discussed herein (e.g., the radio 122, theaudible output device 124 and the sensor 126). For example, in someembodiments, the adapter 120 can include an electronic circuit systemhaving one or more switches of the type disclosed above with referenceto the electronic circuit system 4900.

The locator 150 can include a radio 152, an audible output device 154,and/or one or more sensors 156, and can be operable to monitor the uservia the sensor 156, communicate with the adapter 120, and/or provide anaudible output. The locator need not include all of the components norperform all of the functions described herein. For example, in someembodiments, a locator according to an embodiment can be devoid of asensor 156. The locator 150 can be operable to be easily located,identified and/or readily accessible by the user and/or third parties.For example, the locator 150 can be a bracelet, a necklace, a keychainfob, a watch, a ring, an adhesive patch, a cellular phone or otherpersonal electronic device, and/or any other suitable object. Thelocator 150 can be a piece of jewelry and/or integrated into a piece ofjewelry. In some embodiments, however, the locator 150 can beinconspicuous, so as to not draw attention to the user. For example, insome embodiments, the locator 150 can be similar to and/or incorporatedwithin an article that is inconspicuous. For example, in someembodiments, the locator 150 can be located on an inner layer ofclothing, incorporated or manufactured as a part of the clothing,incorporated into a common accessory, fabricated to resemble a standardkey fob, or the like. In other embodiments, the locator 150 can beconspicuous such that, in the event of a medical emergency, bystanderscan readily identify and/or locate the locator 150, which can, in turn,allow the bystander to identify and/or locate the medicament deliverydevice 100. In yet other embodiments the locator 150 can be configuredto transition between an inconspicuous configuration and a conspicuousconfiguration. Similarly, stated, in some embodiments the locator 150can be inconspicuous in a standby state, e.g., when there is no medicalemergency, and conspicuous in an active state, e.g., when there is amedical emergency, and/or when activated by the user. For example, thelocator 150 can emit an alert, such as an alarm or recorded instructionvia the speaker 154 and/or can have flashing lights, vibration (hapticoutput) and/or any other suitable mechanism to draw attention when thelocator 150 is in the active (or conspicuous) state. Similarly stated,the locator 150 can include any suitable mechanism for changing betweena first configuration and a second configuration in response to an event(e.g., a medical emergency, a notification received from a doctor,pharmacy or the like).

In some embodiments, as discussed in further detail here, acommunication device, such as a cellular phone can be the locator 150and/or be adapted to perform the functions of the locator 150 asdescribed herein. For example, a cellular telephone can execute anapplication operable to monitor the user via the sensor 156, communicatewith the adapter 120, and/or provide an audible output via the audibleoutput device 124.

The locator 150 can communicate with the adapter 120 via the radio 152.The communication between the locator 150 and the adapter 120 can beinitiated by any suitable method, including manual initiation and/orautomatic initiation. In some embodiments, the communication between thelocator 150 and the adapter 120 can be initiated by pushing a button. Inother embodiments, the locator 150 can be activated by a signal from thesensor 156 and/or the sensor 126. In this manner, for example, thecommunication can be initiated when the sensor 156 detects a significantchange in the user's vital signs. In some embodiments, the locator 150and the adapter 120 can establish and maintain a substantiallycontinuous and/or periodically verified communications link. If the linkis severed, e.g., the locator 150 moves out of communications range fromthe adapter 120, the locator 150 and/or the adapter 120 can emit asignal, such as an audible or visual alarm, to alert the user to thebroken connection. Such an embodiment could reduce the likelihood of theuser forgetting to carry the adapter 120 and/or the locator 150together.

In use, the locator 150 and the adapter 120, can cooperatively functionto aid the user in identifying and/or locating the adapter 120, whichcan, in turn, aid the user in locating the medicament delivery device100. For example, when actuated the locator 150 can send a signal, e.g.,via the radio 152, to the adapter 120 to cause the adapter 120 and/orthe medicament delivery device 100 to emit a human-perceivable signal,such as an audible or visual alert. The human perceivable signal can beoperable to draw the user's attention to the adapter 120.

In some embodiments, the locator 150 and/or the adapter 120 can beoperable to calculate and/or report a distance between and/or adirection of the locator relative to the adapter 120. For example, theadapter 120 and the locator 150 can be operable to calculate theirrespective positions relative to each other, for example based on thestrength and/or direction of a radio signal, triangulation,trilateration, GPS, or any other suitable means. In such embodiments,the locator 150 can direct the user to the location of the adapter 120based on the calculation of the relative positions. This arrangement canallow, for example, the locator 150 and/or the adapter 120 to produce adynamic alert based on the change in relative position of the locator150 and the adapter 120. For example, in some embodiments, the adapter120 can emit a pulsed audible output when communication with the locator150 is established. Based on the calculated relative position and/ordistance between the adapter 120 and the locator 150, an intensity,frequency and/or magnitude of the audible output can change. Inparticular, the frequency and/or magnitude of the audible output (e.g.,a beep) can get higher and/or louder as the locator 150 is moved closerto the adapter 120 (and/or the medicament delivery device 100). In thismanner the adapter 120 and/or the locator 150 can include and/or operateas a proximity detector.

In some instances, a person requiring administration of a medicament, “apatient,” may not be the person administering the delivery of themedicament (referred to herein as “a user”). For example, the medicamentcontained in the medicament delivery device 100 may be intended foradministration in a medical emergency, during which the patient may beincapacitated. For example, in some embodiments, the medicament deliverydevice (e.g., the medicament delivery device described above withreference to FIGS. 1-34) may be intended to deliver epinephrine in theevent of an anaphylactic crisis, or to deliver naloxone in the event ofan opioid overdose, or any other potentially life-saving medication. Insuch an emergency, the patient may not be able to operate the medicamentdelivery device 100. Accordingly, as described herein, in suchcircumstances, the monitor 150 can detect the presence of a medicalcondition (e.g., via sensor 156), can produce an instruction, alert orother notification (e.g., via the audible output device 154), and caneither prompt the third party care giver to initiate communication withthe adapter 120 or automatically establish such communications. Forexample, in some embodiments the sensor 156 can be operable to detectphysiological parameters associated with the patient, such as heartrate/pulse, respiratory rate, blood sugar, blood oxygen, an immuneresponse, acceleration (e.g., associated with a fall), brain activity,and/or the like. In the event the locator 150 detects an abnormalcondition that may require medical attention, the locator 150 can emit asignal to be received by the adapter 120, such that the adapter canprovide an indication, instruction or the like as discussed herein. Inthis manner, the locator 150 can also function as a “monitoring device.”

In some embodiments, the locator 150 and any of the monitoring devices,adapters and/or locators described herein can be configured to send awireless signal in response to the detection of an abnormal condition orpotential emergency. In particular, in some embodiments, the locator 150and/or any device operably coupled thereto can automatically dial anemergency number such as, for example, 911 (emergency dispatcher),and/or send information associated with the location of the deviceand/or the end user location through GPS satellite positioning ornetwork based positioning (using cell phone towers).

In other embodiments, the locator 150 can be triggered by anon-emergency event. For example, in some embodiments, the sensor 156can be configured to measure environmental conditions or the like (e.g.,temperature, humidity, presence of certain allergens, etc.) andestablish communications with the adapter 120 based on suchmeasurements. For example, in some embodiments, the medicament deliverydevice 100 can be an inhaler, and the locator 150 can measure andanalyze environmental data such that the locator 150 can alert thepatient and/or user to use the inhaler.

Although the locator 150 is shown as including a sensor 156, in otherembodiments, the locator 150 need not include any sensors. For example,in some embodiments, the locator 150 be conspicuous and/or include aconspicuous label such that a third party will recognize the locator150, and can then manually initiate communication with the adapter 120(e.g., by pressing a switch, similar to actuating a “page” feature). Forexample, in some embodiments, the locator 150 can include a conspicuousstart button that, when pushed, results in a message being produced bythe locator 150. The message can state, for example, “THE PERSON WEARINGTHIS IDENTIFIER IS CARRYING AN AUTO-INJECTOR TO TREAT SYMPTOMS RELATEDTO . . . IF THIS PERSON IS EXHIBITING SUCH SYMPTOMS, PLEASE LOCATE THEAUTO-INJECTOR, WHICH IS NOW BEEPING, AND FOLLOW THE NEXT SET OFINSTRUCTIONS.”

Although the adapter 120 is shown as being a separate component that iscoupled to a medicament delivery device 100 (e.g., such a sleeve, andadapter, or the like), in other embodiments, the functionality of theadapter 120 can be incorporated into the medicament delivery device 100,such that the locator 150 communicates and/or interacts directly withthe medicament delivery device 100 to perform the functions describedherein.

Although shown as interacting with a single medicament delivery device100, in other embodiments, an adapter 120 can interact with more thanone medicament delivery device 100. In other embodiments, a locator 150can interact with more than one adapter 120 and/or medicament deliverydevice 100. For example, FIG. 36 shows a medicament delivery systemincluding a locator 250, a first adapter 220A that can be operable tointeract with a medicament delivery device 200 and a second adapter 220Bthat can be operable to interact with a medicament container 260. Thelocator 250 can include a radio 252, an audible output device 254,and/or one or more sensors 256, and can be operable communicate with theadapter 220A and the adapter 220B, and/or provide an audible output, ina similar manner as described above with reference to the locator 150,and as described below.

In particular, the locator 250 can communicate with the adapter 220A toconfirm the existence of, identify and/or locate the medicament deliverydevice 200, as described above with reference to the locator 150 andadapter 120. Thus, the adapter 220A can include any of the structure andcomponents, and can function similar to any of the adapters describedherein. In this manner, in the event of a medical condition involvingthe medicament in the medicament container 260 (e.g., an overdose), theadapter 220A can assist the user (or patient) in locating the medicamentdelivery device 200. In addition, because the locator 250 is incommunication with the adapter 220B, the locator 250 and/or the adapter220B can, as described below, provide compliance and/or historicalinformation related to the use of the medicament in the medicamentcontainer 260 (e.g., how many pills were recently removed from thecontainer), as well as instructions and/or assistance in identifyingand/or locating the medicament delivery device 200.

The adapter 220B includes a sensor 226 to monitor location, use history,fill level and/or any other suitable parameter associated with themedicament container 260 and/or the medicament delivery device 200. Inthis manner, when the locator 250 is activated (e.g., by a user), thelocator and the adapter 220B can provide information to the userregarding the status of the medicament. In addition to assisting in thelocation of the medicament delivery device 200, providing suchinformation can be important in determining the appropriate course ofaction. For example, in some embodiments, the adapter 220B can beoperably coupled to the medicament container 260, and the sensor 226 canbe operable to determine, measure, record, and/or otherwise monitor thecontents and/or the use of the medicament container 260. In someembodiments, the sensor 226 can measure the weight, volume, quantity,and/or any other appropriate parameter of the medicament within themedicament container 260. The sensor 226 can be an optical sensorconfigured to align with a window of the medicament container 260 tomeasure color, fill level, turbidity, and/or any other suitableparameter. In some embodiments, the sensor 226 can detect when the capof the medicament container 260 is removed, when the medicament isadministered, the amount of medicament in the medicament container 260,withdrawal of medicament from the medicament container 260, and/orchanges in the volume and/or mass of the contents of the medicamentcontainer 260. In this manner, the adapter 220A can provide the user, anemergency first responder, and/or any other person information regardingthe contents and/or usage history of the medicament container 260.

In one example, the medicament container 260 includes a pain medication,such as opioids. In the event of an overdose, information regarding theidentity and usage history of the opioids may be relevant to thetreatment of the patient. If the patient has recently received a largedose of opioids, it may be necessary to treat the patient for anoverdose, for example by administering an opioid antagonist. Bymonitoring the medicament container 260, the adapter 220B (either aloneor in conjunction with the locator 250) can alert a user (e.g., a thirdparty) if treatment is needed. The adapter 220B can cooperativelyfunction with the locator 250, the medicament delivery device 200(and/or the adapter 220A or sleeve of the device) to produce a signaland/or indication identifying and/or locating the medicament deliverydevice. In particular, the adapter 220A, the adapter 220B and/or thelocator 250 can produce and signals and/or provide any indications in asimilar manner as the adapter 120 and/or the locator 150 describedabove. For example, the adapter 220A and/or the locator 250 can alsoinstruct the user to use the medicament delivery device 200, which caninclude the opioid antagonist.

In another example, the medicament delivery device 200 and/or themedicament container 260 can include a dose of vaccine, such as ahepatitis B vaccine or an HPV vaccine to be administered within acertain time period. The sensor 226 of the adapter 220B can be operableto monitor the storage time and/or temperature of the medicamentdelivery device 200 and/or the medicament container 260 to improve thelikelihood that an efficacious dose of medicament is delivered. If themedicament delivery device 200 and/or the medicament container 260 isnot used within a predetermined time period, the adapter 220B can alertthe user and/or a caregiver, such as a prescribing doctor, healthcareprovider, or insurance company that the medicament has not yet beendelivered. For example, the adapter 220B can emit an audible and/orvisual alert, e.g., via the audible output device 224. In addition oralternatively, the adapter 220B can send an electronic signal via theradio 222 operable to alert the user and/or healthcare provider (eitherdirectly to a remote device, such as a smart phone, or via the locator250).

In some embodiments, the adapter 220B and/or the adapter 220A can beoperable to receive a signal via the radio 222 (although the radio 222is not shown as being included within the adapter 220A, it is understoodthat the functionality of the adapter 220A can be the same as or similarto the functionality of the adapter 220B). In some embodiments, forexample, the healthcare provider can remotely query the adapter 220regarding the status and/or use history of the medicament deliverydevice 200 and/or medicament container 260. In this way, the healthcareprovider can determine whether the medicament delivery device 200 and/orthe medicament container 260 has been used within the predetermined timeperiod and/or can schedule follow-up contact and/or care based on theuse of the medicament delivery device 200 and/or the medicamentcontainer 260.

In some embodiments, the locator 250 and/or the adapter 220B can beincluded within and/or can be a portion of a container within which themedicament container 260 is disposed (e.g., for storage, shipping or thelike). For example, in some embodiments the medicament container 260 canbe disposed within the adapter 220B, such that the sensor 226 and/or theother components of the adapter 220B are operably coupled to themedicament container 260. In other embodiments, the adapter 220B can becoupled to and/or can be a portion of the medicament container 260. Forexample, the adapter 220B can be a cap of the medicament container 260,an insert for the medicament container 260, a dispenser for themedicament container 260, a sleeve, a case, and/or label of themedicament container 260.

In some embodiments, the system can include the adapter 220B that iscoupled to the medicament container 260 external to the housing ormedicament contained therein. For example in some embodiments theadapter 220B can be a sleeve and/or label of the medicament container260. In other embodiments, the system can include an adapter 220B thatis coupled within the medicament container 260. For example, in someembodiments, the adapter 220B can be included within a desiccant packagecontained within the medicament container 260, on an interior surface ofthe medicament container 260. Similarly, the adapter 220A can be coupledto, included within and/or can be a portion of the medicament deliverydevice 200. For example, in some embodiments, the adapter 220A can be amouth piece that is removably coupled to an inhaler.

Although not shown in FIG. 36, the adapter 220A can include any of thefunctionality of the adapter 220B described above. For example, theadapter 220A can include a sensor and/or a switch to determine aparameter associated with of operation of the medicament delivery device200. For example, in some embodiments, the adapter 220A can be coupledto an inhaler (or other multi-dose device), and can track the patient'scompliance in using the device. In this manner, the adapter 220A and/orthe adapter 220B can function, either independently, in conjunction witheach other and/or in conjunction with the locator 250 as “smart sleeves”to improve the efficacy of the dosages contained in either themedicament container 260 or the medicament delivery device 200.

Although described, at least in part, as relating to an emergencysituation, the systems and methods described herein can be easilyextended to non-emergency situations. For example, in a chronic-caresetting a patient can purchase an initial kit that includes the adapters220A and 220B, and one or more locators 250 configured to communicatewith the adapters, as described herein. The user can removably couplethe adapter 220B to the medicament container 260 and/or the adapter 220Ato the medicament delivery device 200, such that upon refilling themedication, the appropriate adapter can be coupled to the replacementmedicament container 260 and/or medicament delivery device 200.

Although the medicament container 260 and the medicament delivery device200 are described above as being separate (although related inapplication), in some embodiments, the medicament container 260 can bedisposed within the medicament delivery device 200. For example, themedicament container 260 can be a vial of medicament disposed within anddelivered by an auto injector, inhaler, and/or other suitable medicamentdelivery device 260. In another embodiment, the medicament container 260can be operable to refill and/or replenish the medicament deliverydevice 200. For example, the medicament container 260 can transfermedicament to the medicament delivery device 200 or, although only onemedicament container 260 is shown, in some embodiments, a kit canmultiple medicament containers 260 (refills). In other embodiments, themedicament container 260 can be used in conjunction with and/orindependently from the medicament delivery device 200. For example, themedicament container 260 can include medicament related to, but notadministered via the medicament delivery device 200. For example, themedicament container 260 can include opioids and the medicament delivery200 device can be operable to deliver an opioid antagonist, such asnaloxone, naltrexone or the like, in the event of an opioid overdose.

Although the adapter 220A and the adapter 220B are shown ascommunicating through the locator 250, the devices shown and describedherein can communicate in a peer-to-peer fashion.

FIG. 37 is a signal diagram illustrating a series of communicationsoperable to increase the likelihood that a patient 3152 receivesappropriate medical care in the event of a medical emergency and/orduring a dosing regimen. In the event that the patient 3152 requirestreatment and needs assistance and/or is not able to operate amedicament delivery device 3100 configured to provide the neededtreatment, it may be necessary to alert a third-party bystander oremergency first responder (a user 3102). As described herein, the alertcan include a notification of the presence of the medicament deliverydevice 3100 and/or provide the user 3102 instructions for the use of themedicament delivery device 3100. As shown in FIG. 37, a system includesa monitoring device 3150, a adapter 3120 and/or a communication device3122 that cooperatively aid the patient 3152 and/or the user 3102 inidentifying the medical emergency, locating the medicament deliverydevice 3100, administering the needed treatment, and/or reporting themedical emergency. Although FIG. 37 shows each of the monitoring device3150, the adapter 3120, the medicament delivery device 3100 and/or thecommunication device 3122, in some embodiments certain functionsattributed to one of these devices can be performed by any other ofthese devices. Moreover, a system and method according to an embodimentneed not include each of these devices.

Each of the monitoring device 3150, the adapter 3120, the medicamentdelivery device 3100 and/or the communication device 3122 can beoperable to send and/or receive signals. The signals can be humanperceivable, such as audible, visual, vibratory and/or haptic alerts. Inother embodiments, the signals can be electromagnetic signals, radiosignals, IR signals and/or signals otherwise not human perceivable. Anembodiment can include both human perceivable and signals that are nothuman perceivable.

As shown by the signal 3210, the monitoring device 3150 is operablycoupled to the patient 3152 and can send and/or receive the signal 3210.More particularly, the monitoring device 3150 is operable to sense whenthe patient 3152 requires the administration of a medicament, e.g., fromthe medicament delivery device 3100, and can produce the signal 3210 inresponse thereto. The monitoring device 3150 can be, for example, asensor operable to detect physiological parameters associated with thepatient 3152, such as heart rate/pulse, respiratory rate, blood sugar,blood oxygen, an immune response, acceleration (e.g., associated with afall), brain activity, and/or the like. In some embodiments, themonitoring device 3150 can be similar to the locator 150 and/or thelocator 250 described above, or any of the other locators describedbelow. For example, in some embodiments, the monitoring device can beintegrated with and/or coupled to a piece of jewelry (e.g., a ring,watch or necklace) worn by the user, or the like.

In the event the monitoring device 3150 detects a condition that mayrequire medical attention, the monitoring device 3150 can emit thesignal 3220 operable to alert the patient 3150 and/or the signal 3220 toalert the user 3102 to the abnormal condition. Signals 3220 and/or 3230can be an audible and/or visual alert, such as an alarm, a strobinglight, and/or a recorded instruction. If the patient 3152 is capable ofresponding the condition (e.g., the patient 3152 is not incapacitated)the patient 3152 can silence the alarm and/or administer the necessarytreatment (e.g., using the medicament delivery device 3100). If,however, the patient 3152 is incapable of responding to the condition(e.g., the patient 3152 is incapacitated), the signal 3230 can notifythe user 3102 that the patient 3152 requires medical attention, that themedicament delivery device 3100 is present, provide instructions forusing the medicament delivery device 3100, and/or instructions forobtaining further information related to the medicament delivery device3100.

In addition to producing the signals 3220 and 3230, the monitoringdevice 3150 can produce the signal 3240 to communicate with an adapter3120, which can be coupled to or integral with the medicament deliverydevice 3100. The adapter 3120 can be similar to the locator devices 120and/or 220 shown and described above. In some embodiments, the adapter3120 can be incorporated into a sleeve within which at least a portionof the medicament delivery device 3100 is disposed (e.g. similar to thesleeve 4200 shown and described above with reference to FIGS. 3-34). Theadapter 3120 can facilitate communication with and/or identification ofthe medicament delivery device 3100.

As described herein, the monitoring device 3150 and the adapter 3120 cancooperate to aid the user 3102 in locating the medicament deliverydevice 3100. For example, signal 3240 can cause the adapter 3120 to emitan audible or visual alert operable to draw the user's 3102 attention,and/or the monitoring device can be operable to ascertain the locationof the adapter 3120, e.g., via radio location techniques, and emit anoutput operable to guide the user to the adapter 3120. For example, themonitoring device 3150 can emit a tone and/or chirp that varies inpitch, frequency, and/or volume as the distance between the monitoringdevice 3150 and the adapter 3120 changes. In this way, the adapter 3120can be operable to guide the user 3102 to the medicament delivery device3100.

As shown as signal 3250, the medicament delivery device 3100 can provideinstructions to the user 3102 and/or can direct the user 3102 to obtaininstructions for the use of the medicament delivery device 3100. Forexample, the instruction can any of the electronic instructionsdescribed herein, such as electronic output OP1 and/or OP2 shown anddescribed above with reference to the medicament delivery device 4000.In some embodiments, signal 3250 can include recorded instructionsregarding the use of the medicament delivery device 3100. In someembodiments, after the medicament delivery device is located, a visualoutput in the form of LCD Display output can direct the user regardinginstructions for using the device.

In some embodiments, either the patient 3152 and/or the user 3102 canpossess the communication device 3122, and the system and/or thecommunication device 3122 can be adapted and/or enabled to perform allor portions of the functions of the monitoring device 3150, the adapter3120 and/or the medicament delivery device 3100. In this manner, thesystem and methods can utilize the communication resources that arecommonly available. In particular, in some embodiments, thecommunication device 3122 can be a smart phone or other portableelectronic device (pager, game system, music system or the like). Insuch embodiments, the systems described herein can be configured toemploy the communication resources (e.g., the speakers, displaycapabilities, signal processing, transmission/reception capabilities, orthe like) of the communication device 3122 to enhance the performance ofthe overall system.

For example, in some embodiments, the medicament delivery device 3100,the monitoring device 3150 and/or the adapter 3120 can include a labelhaving a machine-readable code. The machine-readable code can be, forexample, a bar code, a QR Code™ and/or an address of a website. Duringan event, the user can scan or otherwise read the machine-readable codeusing the communication device 3122 (e.g., a cellular phone) to accessinstructions. For example, in some embodiments, upon scanning themachine-readable code, the user's cellular phone will be directed to awebsite or other location in which instructions for using the medicamentdelivery device 3100 and/or otherwise treating the patient are provided.In other embodiments, the label can include a text message prompting theuser to scan the machine-readable code with the patient's communicationdevice 3122. In a similar manner, the patient's communication device canbe directed to a web site or other location in which instructions forusing the medicament delivery device 3100 and/or otherwise treating thepatient are provided 3122. Moreover, the patient's communication device3122 can include information unique to the patient, such as, forexample, a listing of contacts to reach in the event of an emergency (insome embodiments, by scanning the machine-readable code, a text messagewill automatically be sent to this list), an application stored locallythat provides detailed instructions unique to the patient or the like.

In other embodiments, the communication device 3122 can enable the user3102 to access the patient's 3152 medical history, provide patientspecific instructions, and/or prompt the user 3102 to notify emergencypersonnel and/or the patient's 3152 emergency contact. For example, insome embodiments, upon detection of an event, the patient'scommunication device 3122 can emit a ring tone prompting the user 3102to access the communication device 3122. Upon accessing the patient'scommunication device 3122, the user 3102 can receive signals and/orinformation related to the patient's medical history or the like.

In other embodiments, the communication device 3122 (e.g., either theuser's mobile computing device or the patient's mobile computing device)can be configured to receive a signal (not shown) from the medicamentdelivery device 3100 and/or the adapter 3120. The signal can bereceived, for example, after the communication device 3122 is used toscan a label, tag or other machine-readable code on the medicamentdelivery device 3100 and/or the adapter 3120. In other embodiments, thesignal can be received automatically (e.g., without the need to scan acode), for example, in response to the manipulation of the medicamentdelivery device 3100. Upon receiving the signal, the communicationdevice 3122 can then transmit visual and audible instructions for usingthe medicament delivery device 3100. In some embodiments, for example,the medicament delivery device 3100 and/or the adapter 3120 can includean electronic circuit system similar to the electronic circuit system4900 shown and described above, except that instead of producing anoutput via LED's (e.g., LED 4958A and 4958B) and/or an audible outputdevice (e.g., device 4956), the electronic circuit system produces awireless signal in response to actuation of the switches therein (e.g.,switches 4926 and 4946). In some embodiments, the wireless signal can bereceived by the communication device 3122 (e.g., either the user'smobile computing device or the patient's mobile computing device). Thecommunication device 3122 can then, in turn, produce the audible andvisual instructions in response to manipulation of the medicamentdelivery device 3100. This arrangement allows the computing and/orcommunication resources of the communication device 3120 to be used toenhance the instructions, locating capabilities and/or the like of thesystems described herein.

Although FIG. 37 is shown and described as having a separate monitoringdevice 3150 and adapter 3120, in some embodiments, some or all of thefunctions of the monitoring device 3150 and the adapter 3120 can becombined in a single device. For example, as shown in FIG. 38, a systemcan include and/or employ a cellular phone 6122 operable to communicatewith the medical delivery device 6100 (e.g., via Bluetooth™). Thecellular phone 6122 can also be configured to communicate with thepatient 6152 and/or the user 6102 (e.g., via audio or visual outputs),and the medicament delivery device 6100 (e.g., via Zigbee™) to aid thepatient 6152 and/or the user 6102 in identifying, locating and/or usingthe medicament delivery device 6100. The medicament delivery device 6100can be similar to the medicament delivery devices shown and describedabove. The locator device 6120 can be similar to the locator devicesshown and described above, and/or can be integrated into the medicamentdelivery device or cover (e.g., the sleeve 4200).

For example, the functions of the monitoring device 3150 described abovecan incorporated into the patient's cell phone 6122 (as indicated by theinclusion of the monitoring device 6150). For example, the monitoringdevice 6150 can be operable to sense when the patient 6152 requires theadministration of a medicament. As described above with reference toFIG. 37, the monitoring device 6150 can be operably coupled to monitorthe patient 6152, as shown by the arrow 6210. The monitoring device 6150can comprise sensors incorporated into and/or operatively coupled to thecell phone 6122, such as accelerometers, gyroscopes, and/or peripheraldevices, such as heart rate monitors. Upon detecting a condition, thepatient's 6152 cell phone can alert the patient 6152 (via signal 6220)and/or the user 6102 (via signal 6230). For example, in someembodiments, the cell phone 6122, can emit an audible, visual, and/orhaptic signal to draw the attention of the patient (e.g., signal 6220)and/or the user (signal 6230). Signals 6220 and/or 6230 can instruct thepatient 6152 and/or the user 6102, respectively, that the patient 6152requires medical attention.

In some embodiments, the system can include one or more sensors externalto the cell phone 6122, but which are coupled to the cell phone, eitherwireless or via a wired connection. For example, in some embodiments thepatient 6152 may wear a monitoring device, such a glucose meter, a heartrate monitor or the like. Although such external devices may produce anaudible alarm, the systems and methods described herein allow thepatient's cell phone 6122 to act as a central “hub” to receive suchsignals, produce an enhanced output, communicate with the medicamentdelivery device 6100 or the like.

The cell phone 6122 can also be operable to display e.g., via a visualoutput device, or emit, e.g., via an audible output device, informationand/or instructions regarding the patient's medical history and/or theadministration of medicament using the medicament delivery device 6100.The cell phone 6122 can also automatically contact emergency personneland/or prompt the patient 6152 and/or the user 6102 to contact emergencypersonnel.

For example, in some embodiments, the cell phone 6122 (either thepatient's cell phone or the user's cell phone) can execute anapplication (e.g., in hardware) that can unlock and/or otherwiseconfigure the cell phone 6122 to be used by the patient 6152 and/or theuser 6102. In some embodiments, the cell phone 6122 can automaticallydisplay a prompt and/or instruction upon detecting a specifiedcondition. Thus, the cell phone 6122 can be configured to be useableand/or provide information to the user 6102 in the event of a medicalemergency without requiring a password or unlock sequence. For example,in some embodiments, the touch screen of the cell phone 6122 can displaya button in response to the detection of a specified condition thatprompts a user (e.g., a third party) to enter the application. In otherembodiments, the cell phone 6122 can display a message prompting theuser to “swipe,” scan or read a particular code thereby unlocking thecell phone for subsequent use as described herein. For example, in someembodiments, the user can be prompted to swipe, scan or read anidentification card, another device, a medicament container or the like.

The cell phone 6122 can aid the user 6102 in administering medicament tothe patient 6152 using the medicament delivery device 6100. For example,the cell phone 6122 can send a signal 6240 to the medicament deliverydevice 6100 to aid the user 6102 in locating the medicament deliverydevice 6100. The cell phone 6122 can provide instructions to assist theuser 6102 in administering a medicament to the patient 6152 via themedicament delivery device 6100.

Although the locators (e.g., locator 150) are shown and described aboveas being “wearable” items, such as a key fob, jewelry or the like, inother embodiments a locator can be a substantially stationary item.Moreover, although the locators (e.g., locator 150) are shown anddescribed above as being unique to a particular patient, in otherembodiments, a locator can be used to track multiple different patientsand/or to communicate with multiple different devices (either differentdevices of the same type or different devices of different types). Sucha locator can be used, for example, in an institutional setting(schools, nursing homes, hospitals or the like) to improve the abilityof patients and user to identify, locate and/or actuate a variety ofdifferent medicament delivery devices. Moreover, in some embodiments, alocator can, in addition to performing the identification and/orlocation features described herein, serve to prevent unauthorized and/orundesired access to medicaments. For example, FIGS. 39-41 depict a kit(or container) 300 according to an embodiment. The kit 300 includes amedicament container 360 containing any suitable medicament. The kit 300can be intended for home and/or institutional use and can bewall-mounted and/or otherwise substantially fixed in a particularlocation. The kit 300 can store and/or dispense a medicament (e.g., fromwithin the medicament container). In some embodiments, the kit 300 candispense an opioid and/or provide access control for an opioid.

The kit 300 also includes a movable portion 318, such as, for example, ahinged lid, that has a first position (see FIG. 39) and a secondposition (see FIGS. 40-41). When the movable portion 318 is in the firstposition, the movable portion 318 covers an internal region 312 definedthe kit 300. Conversely, when the movable portion 318 is in the secondposition, at least a portion of the internal region 312 of the kit 300is exposed. Said another way, when the movable portion 318 is in thesecond position, the medicament container 360 can be removed from theinternal region 312 of the kit 300.

The container or kit 300 includes an electronic circuit system 322 thatis operatively coupled to and/or includes a radio 324, a first switch336, and a second switch 337. The switches can be operably coupled toany suitable mechanism. In particular, the first switch 336 is coupledto a lock mechanism (not shown) that, when in the locked configuration,will prevent the movable portion 318 from being moved into the openedposition. The electronic circuit system 322 is includes an actuator orother mechanism configured to cause the first switch 336 to move betweena first state (e.g., closed) and a second state (e.g., opened) when theradio 342 receives a signal from an access control device 310 and/or theelectronic circuit system 322 validates the signal. When the firstswitch 336 is in its second state (e.g., opened) the locking mechanismis “unlocked” such that the movable portion 318 can be moved between itsfirst position and its second position, as indicated by arrow E in FIG.40. In this manner, the patient or user can only access the medicamentcontainer when the access control device 310 is present and ismanipulated to send the access signal.

The access control device 310 can be, for example an RFID device. Theelectronic circuit system 322 can log information associated with theaccess control device 310, such as a unique identifier (e.g., when thekit 300 is configured to be accessed by more than one user each having aunique access control device 310), time of access, number of accessattempts, time between access attempts, etc. In some embodiments, theelectronic circuit system 322 can be configured to only allow access tothe contents of the kit 300 (e.g., only move the first switch 336 fromthe first state to the second state) at certain times, after certainintervals, and/or to certain individuals. The radio 324 can transmit asignal associated with usage history to, e.g., a remote monitoringdevice (such as a computer), and/or receive and respond to a queryregarding usage history.

As an example, the medicament container 360 can include a controlledsubstance and/or a medicament with potentially dangerous side effects,such as an opioid. This arrangement limits access to the medicamentcontainer 360 the identity of the user (e.g., via the access controldevice 310), based on time, past usage, and/or quantity. In someembodiments, access to the medicament container 360 can also be limitedto patients having a medicament delivery device (e.g., an auto-injector)containing an opioid antagonist. In this manner, the system ensuresaccess to the opioid only when there exists the likelihood that rapidtreatment will be available in the event of an overdose (i.e., via thepresence of the medicament delivery device). In such an embodiment, themedicament delivery device containing the opioid antagonist can be orinclude the access control device 310. The medicament delivery devicecan include, for example, an RFID chip detectable by the radio 324. Whenthe patient presents the medicament delivery device (the access controldevice 310), the electronic circuit system can identify the user anddetermine whether to grant access to the medicament.

The second switch 337 is configured to move between a first state (e.g.,closed) and a second state (e.g., opened) when the medicament container360 is removed from the internal region 312 of the kit 300, as indicatedby the arrow F in FIG. 41. The electronic circuit system 330 can beconfigured to log the removal of the medicament container 360 inresponse to the changing state of the switch. The electronic circuitsystem can associate the removal of the medicament container 360 with auser identifier provided by the access control device 310. In someembodiments, second switch 337 can be operable to determine the quantityof medicament removed from the interior region 312 of the kit.

In some embodiments, the electronic circuit system 330 can be configuredto cause the radio 324 to transmit a signal associated with the removalof the medicament container 360 from the interior region 312 of the kit300. For example, in some embodiments, the kit 300 can communicate witha computer (not shown) to log medicament usage and/or send notifications(e.g., notify medical providers, notify emergency personnel, notifypre-programmed contact personnel, etc.).

In some embodiments, the electronic circuit system 330 can be configuredto output an audible and/or visual output, for example via a speakerand/or an LCD screen when the second switch 337 is moved from its firststate to its second state, for example, a recorded speech output and/ora video output associated with an identification of the medicamentcontainer 360, an identification of patient symptoms (e.g., instructionsfor assessing the physical condition of the patient) and/or aninstruction for using the medicament. For example, in some embodimentsthe output can be an audio-visual output via both a speaker and an LCDscreen step-by-step instructions for using the medicament.

Although the movable member 318 is shown and described as being a hingedlid, in some embodiments, the movable member can be coupled to thecontainer in any suitable fashion. For example, in some embodiments, themovable member 318 can be a removable cover that is slidingly coupled tothe container. In other embodiments, the movable member 318 can be aremovable cover that is threadedly coupled to the container (i.e., aremovable cap). In yet other embodiments, the movable member 318 can bea removable cover that is coupled to the container via an interferencefit. In yet other embodiments, the movable member 318 can be a frangiblecover that is irreversibly removed from the container during use of themedical device. For example, in some embodiments the movable member 318can be a frangible cover that provides a tamperproof seal, a sanitaryseal, or the like.

Although the containers, kits and/or adapters are shown and described insome instances above as being rigid, box-like containers, in otherembodiments, a container, kit and/or adapter can have any suitable shapeand/or flexibility. For example, in some embodiments, a container, kitand/or adapter can be a flexible, pouch-like container. Such acontainer, kit and/or adapter can be more easily carried in certaincircumstances, such as, for example at outdoor events (e.g., children'scamps, concerts, picnics or the like). In other embodiments, acontainer, kit and/or adapter can be a tube or sheath (e.g., similar tothe cover 4200 described above) configured to contain all or a portionof a medicament delivery device 360.

Although FIGS. 39-41 depict and describe a medicament container 360removable from the interior region 312 of the container or kit 300, inother embodiments, the kit 300 can be operable to dispense medicamentwithout a container 360. For example, the kit 300 can be operable todispense medicament tablets, pills, liquid, aerosols, and/or any othersuitable medicament form. In such embodiments, the movable member 318can be a dispensing mechanism configured to meter a quantity ofmedicament. For example, the moveable member 318 and/or the secondswitch 337 can be operable to count and dispense an appropriate numberof pills. The moveable member 318 and/or the second switch 337 can alsoinclude a loss-in-weight meter, a volumetric pump, and/or any othersuitable mechanism for dispensing, metering, and/or measuring theremoval of medicament and/or medicament container(s) 360 from theinterior region 312.

In some embodiments, the medicament container 360 can be a medicamentdelivery device and/or the medicament container 360 can be disposedwithin a medicament delivery device. In such an embodiment, themedicament delivery device can be similar to the medicament deliverydevice 4000 shown and described above.

FIG. 42 depicts a schematic illustration of a medicament delivery device11002 operable to be coupled to a case or cover 11197. The medicamentdelivery device 11002 can be similar to the medicament delivery devicesshown and described above, such as medicament delivery device 4000. Thecase 11197 can be a case operable to be physically and/or electricallycoupled to the medicament delivery device 11002 and a communicationdevice 11990 (e.g., a cell phone). The case 11197 can be a sleeve (suchas the cover 4200 described above), a flexible pouch or the like. Thecase 11197 includes an electronic circuit system 11920. The electroniccircuit system 11920 can be any electronic circuit system of the typeshown and described herein. For example, the electronic circuit system11920 can be configured to monitor the status of the medicament deliverydevice 11002, interact with (or be actuated by) to produce a signal,actuate the medicament delivery device 11002, provide instructions forusing the medicament delivery device 11002 or the like.

In some embodiments, the medicament delivery device 11002 can include asafety guard that is moved prior to administering the medicament and anactuator that is moved to initiate delivery of the medicament. Thesafety guard can be similar to safety lock 4700 shown and describedabove. The actuator can be similar to the base 4300 shown and describedabove. In some embodiments, the medicament delivery device 11002 and/orthe case 11197 can detect that the medicament delivery device 11002 isready for use and send a signal to the communication device 11990. Inresponse, the communication device 11990 (e.g., the cell phone) canprovide instructions to the patient and/or user regarding the use of themedicament delivery device 11002. For example, in some embodiments,movement of the safety guard (to place the medicament delivery device11002 in a “ready” configuration) can trigger the electronic circuitsystem 11920, causing the case 11197 to “detect” the status of themedicament delivery device 11002. The case 11197 can then send a signalthat is received by the communication device 11990 such that anapplication running on the communication device 11990 providesinstructions. In some embodiments, the communication device 11990 can beoperable to send a signal, such as an alert to a pre-programmedemergency contact via the communication network 11999.

In some embodiments, the case 11197 can include sensors and/or canreceive signals from the medicament delivery device 11002. In thismanner, the case 11197 can transmit information associated with the useof the medicament delivery device 11002 to the communication device11990. The communication device 11990 can provide instructions to thepatient and/or user based on the status and/or a change in configurationof the medicament delivery device 11002. For example, the communicationdevice 11990 can provide different instructions associated with theremoval of a safety guard, positioning the medicament delivery device11002 and/or case 11197 against a body part, and/or triggering themedicament delivery device 11002 (e.g., movement of an actuator orbase).

In some such embodiments, the communication device 11990, the case11197, and the medicament delivery device 11002 can be communicativelycoupled such that the status and/or use of the medicament deliverydevice 11002 can be remotely monitored. For example, the case 11197 canbe operable to report the status of the medicament delivery device 11002to a remote server via the communication device 11990 and thecommunication network 11999.

In some embodiments, a case or cover can be configured to removablycontain at last a portion a medicament delivery device and acommunication device (e.g., a cell phone). In this manner, the case canoperably couple a medicament delivery device to an off-the-shelfcommunication device to produce a “smart” medicament delivery device.For example, FIGS. 43 and 44 are schematic diagrams of a case 21197coupled to a medicament delivery device 21990 and a cell phone 21002.The medicament delivery device can be similar to the medicament deliverydevice 4000 as shown and described above or any other suitable device.The case 21197 can define a first volume operable to contain themedicament delivery device 21990 and a second volume operable to containa cell phone 21002. Thus, the case 21197 can couple the medicamentdelivery device 21990 to the cell phone 21992, thereby increasing thelikelihood that the medicament delivery device 21990 is available in theevent that a medicament is needed.

The case 21197 contains an electronic circuit 21920. The electroniccircuit system 21920 can be operable to store, process and/or produceelectronic signals associated with the use of the medicament deliverydevice 21990. The electronic system 21920 can be similar to any of theelectronic circuit systems shown and described herein. Moreover, theelectronic system 21920 is communicatively coupled to the cell phone21002. The electronic system 21920 can be communicatively coupled to thecell phone 21002 via any suitable mechanism, such as, for example via awired configuration (via the docking port, USB port, or other port onthe cell phone 21002), via a physical connection (e.g., via a member,switch actuator or the like that transmits input to the cell phone 21002via the touch screen or other buttons on the cell phone 21002) orwirelessly via an RF or optical signal. In some embodiments, theelectronic circuit system 21920 can provide an input to the cell phone21002 via a microphone of the cell phone 21002. For example, in someembodiments, manipulation of the case 21197 and/or the medicamentdelivery device 21990 disposed therein (as described below) can resultin the electronic circuit system 21920 producing a pressure wave (eitheraudible or inaudible) having a particular frequency or pattern offrequencies that is detectable by the microphone. In this manner, theelectronic circuit system 21920 can trigger the cell phone to send asignal, run an application, or the like, based on the status and/orchange in configuration of the medicament delivery device 21990.

In some embodiments, the electronic circuit system 21920 can be operablycoupled to the medicament delivery device 21990. In some embodiments,the case 21197 and/or the electronic circuit system 21920 can bephysically, but not electronically coupled to the medicament deliverydevice 21990. In such an embodiment, the case 21197 can be operable tomonitor the status of (e.g., to receive input from) the medicamentdelivery device via physical changes and/or forces applied by or to themedicament delivery device 21990, as described in more detail herein.

The medicament delivery device 21990 includes a safety tab 21995 and anactuator 21997. The safety tab 21195 and the actuator 21997 can be, forexample, similar to the safety lock 4700 and the base 4300,respectively, shown and described above. As shown, in FIG. 43, a portionof the safety tab 21995 is disposed outside of the case 21997 prior touse of the medicament delivery device 21990. In this manner, althoughthe medicament deliver device 21990 is disposed within and/or is coveredby the case 21977, the user can prepare the medicament delivery device21990 for actuation by accessing the exposed portion of the safety tab21995. The safety tab 21995 can be removed before using the medicamentdelivery device 21990 as indicated by arrow G in FIG. 43. Moreover,removing the safety tab 21995 can cause the medicament delivery device21990 to change position (i.e., to a “ready position”) within the case21197. In this manner, a delivery member (e.g., a needle) of themedicament delivery device 21990 can be moved in proximity to theopening through which the safety tab 21995 was disposed, therebypreparing the device to deliver the medicament therein.

When the safety tab 21995 is removed, the medicament delivery device21990 can be secured in the ready position by a movable retainingportion 21924 of the case 21197. The retaining portion 21924 can be aspring-actuated tab, a deformable portion of the case 21197 or the likethat, upon movement of the proximal edge of the medicament deliverydevice 21990, is released to limit movement of the medicament deliverydevice 21990. Additionally, the electronic circuit 21920 can sense thatthe retaining portion 21924 has secured the medicament delivery device21990 in the ready position and can send a signal to the communicationdevice 21002. In response, the cell phone 21002 can provide aninstruction to the user and/or send a signal to a remote monitoringdevice, e.g., via a network, an emergency dispatch system (911 call) orthe like. For example, the cell phone 21002 can instruct the user toplace the case 21197 against the thigh and/or send a notification, suchas an SMS message to a pre-programmed emergency contact.

The electronic circuit 21920 can sense that the retaining portion 21924has secured the medicament delivery device 21990 via any suitablemechanism, such as, for example, a switch that is actuated upon movementand/or removal of the safety tab 21995, movement of the housing of themedicament delivery device 21990 or release and/or movement of theretaining portion 21924.

In some embodiments, the case 21197 can include a sensor 21992 (see FIG.44) operable to detect if the case 21197 and the medicament deliverydevice 21990 are positioned against the body of the user. Accordingly,the electronic circuit system 21920 can send a signal to thecommunication device 21002 when the sensor 21922 detects that the caseis properly positioned. In response, the communication device 21002 canprovide an instruction to the user and/or send a signal to a remotemonitoring device. For example, the communication device 21002 caninstruct the user to actuate the medicament delivery device and/or senda notification, such as an SMS message to a pre-programmed emergencycontact.

With the medicament delivery device 21990 in the ready position, asindicated in FIG. 44, the actuator 21997 is exposed and/or is disposedat least partially outside of the case 21997. In this manner, themedicament delivery device 21990 can be actuated by moving an actuator21997, as indicated by arrow H. Actuating the medicament delivery device21990 can cause it to deliver a medicament (e.g., as described abovewith reference to the device 4000). The electronic circuit system 21924can detect that the medicament delivery device 21990 has been actuated,for example, by detecting a force associated with actuation against theretaining portion 21924, and can provide an instruction to the userand/or send a signal to a remote monitoring device. For example, thecommunication device 21002 can instruct the user to seek medicalattention, and/or send a notification, such as an SMS message to apre-programmed emergency contact. In other embodiments, a portion of theactuator 21997 can actuate and/or contact a switch of the electroniccircuit system 21920 such that a signal is sent to the cell phone 21002.

In this manner, the electronic circuit system 21920 can send electronicsignals associated with the status, use, and/or other function of themedicament delivery device to and/or receive electronic signals from acommunications network via the cell phone 21002.

While various embodiments of the invention have been described above, itshould be understood that they have been presented by way of exampleonly, and not limitation. Where methods described above indicate certainevents occurring in certain order, the ordering of certain events may bemodified. Additionally, certain of the events may be performedconcurrently in a parallel process when possible, as well as performedsequentially as described above.

For example, although electronic circuit systems are shown and describedabove as outputting one or more outputs directed towards a single,immediate user, in some embodiments, a locator device and/or monitoringdevice can output multiple outputs directed towards multiple differentclasses of users. For example, in some embodiments, the locator deviceand/or monitoring device can output a first output to the immediate userand second output to a remotely located emergency response team. In suchembodiments, the second output can be, for example, a phone call, SMS, apage, an e-mail or the like. For example, in some embodiments, thesecond output can be an e-mail to the parents and/or caregivers of achild. Moreover, such a second output can be transmitted eitherwirelessly or through a wired network.

Although the electronic circuit systems are shown and described above asoutputting one or more outputs in response to one or more switches, inother embodiments an electronic circuit system can output an electronicoutput in response to any number of different inputs. For example, insome embodiments, an electronic circuit system can output an electronicoutput based on input from the user provided via a keyboard, a touchscreen, a microphone or any other suitable input device. In this manner,the electronic outputs can be produced in response to direct feedbackfrom the user.

Although the embodiments of FIGS. 39-41 are shown and described asreceiving a signal from an access control device 310, in otherembodiments, a user could enter a password PIN or other personallyidentifiable information to the kit 300 via a keyboard, touch screen,voice command and/or any other suitable device.

Although the kit 300 of FIGS. 39-41 are shown and described ascontaining a removable medicament container 360, in other embodiments,the kit 300 can dispense a medicament directly, and/or can dispense amedicament delivery device.

Some embodiments described above include an adapter (or medicamentdelivery device) and a locator device operable to communicate with eachother and/or locate each other. The monitoring device and/or the locatordevice can communicate via Bluetooth™, WiFi, a cellular telephonenetwork, a satellite pager network, localized AM or FM radio signals,Broadcast AM, FM, or satellite radio, RFID signals, human audible orinaudible sound waves, IR, Zigbee™, X10, and/or any other suitablesignal. In some embodiments, the monitoring device and/or the locatordevice can be operable to locate any other device via, audible, visual,radio, GPS, and/or any other suitable location technique. The monitoringdevice and or the locator device can aid a user in locating a medicamentdelivery device by, for example, causing the medicament delivery deviceand/or the locator device to emit a audible, visual, and/or tactilealert. The alert can vary in power, frequency, and/or any other suitableparameter as the monitoring device and/or the locator device are broughtcloser to the medicament delivery device.

Any of the radios, transmitters, receivers, and/or transceiversdescribed herein can be operable to transmit, receive, repeat, and/orotherwise interact with electromagnetic signals. Electromagnetic signalscan be of any suitable frequency. For example, the radios, transmitters,receivers, and transceivers can be operable to transmit and/or receiveIEEE 802.11 signals, Bluetooth™ signals, FM radio signals, AM radiosignals, cellular telephone signals, satellite pager signals, RFIDsignals, GPS signals, and/or any other suitable electromagnetic signal.

In some embodiments, a medicament delivery device is shown and describedas an auto-injector. In other embodiments, the medicament deliverydevice can be a patch configured to adhere to the patient. The patch canrelease a medicament, for example, after receiving a signal that medicaltreatment is needed. The patch can receive the signal from, for example,a monitoring device. In other embodiments, the medicament deliverydevice can be an injector configured to be carried in a pocket of thepatient's garments. The injector can be configured to inject amedicament, for example, after receiving a signal that medical treatmentis needed.

In some embodiments, a locator device and/or a medicament deliverydevice can include an electronic circuit system and/or a sensor and beoperable to output an electronic output. Such a sensor can include, forexample, a proximity sensor (e.g., to determine the position of themedicament delivery device), a temperature sensor, a pressure sensor, anoptical sensor or the like. For example, in some embodiments, thecontainer can include a temperature sensor configured to sense thetemperature of the medicament contained within the medicament deliverydevice. In this manner, the electronic circuit system can output aninstruction and/or a status message when the medicament is too cold foreffective delivery. For example, in some embodiments, when themedicament is too cold for effective delivery (this may occur, forexample, if the container is being used in an outdoor setting), theelectronic circuit system can output a message, such as, for example,“Medicament is too cold—please briskly rub the auto-injector betweenyour hands before using.”

Although in some embodiments the electronic circuit systems are shownand described above as outputting a single output in response to aninput (e.g., the removal of a medicament delivery device, the change inposition of a hinged lid, etc.), in other embodiments, an electroniccircuit system can output a sequence of electronic outputs in responseto such an input. In some embodiments, for example, when a medicamentdelivery device is removed from a container, an electronic circuitsystem can output a predetermined sequence of use instructions over apredetermined time period. For example, upon removing the medicamentdelivery device, the first instruction can be an audible outputindicating the type of medicament delivery device removed. After apredetermined time period, the electronic circuit system can then outputa second instruction, which can be a visual output instructing the userin how to diagnose the patient and/or prepare the patient for themedicament. In a similar manner, the electronic circuit system canprovide additional outputs to instruct the user in the use of themedicament delivery device. Moreover, in some embodiments, theelectronic circuit system can output an output instructing the user inpost-use procedures, such as for example, the disposal of the medicamentdelivery device, instructions for follow-up treatment or the like.

For example, although the electronic circuit systems are shown anddescribed above as being configured to output primarily audible andvisual outputs, in other embodiments, an electronic circuit system canbe configured to produce any suitable output. For example, in someembodiments, an electronic circuit system can produce a haptic output,such as a vibratory output produced by a piezo-electric actuator. Inother embodiments, an electronic circuit system can produce a thermaloutput, produced by a heating or cooling element.

Although some embodiments describe a recorded message output in English,in other embodiments, the electronic circuit system can output recordedspeech in any language. In yet other embodiments, the electronic circuitsystem can output recorded speech in multiple languages. In yet otherembodiments, the user can select the language in which the recordedspeech is to be output.

Medicament delivery devices shown and described above can be single-usemedical injectors, or any other suitable device for delivering one ormore doses of a medicament into a patient's body. For example, in someembodiments, a medicament delivery device can be a pen injectorcontaining multiple doses of a chronic-care medicament, such as, forexample, insulin. In such embodiments, an electronic circuit system canoutput instructions associated with not only an initial use of themedicament delivery device, but also associated with repeated uses,dosage monitoring or the like. In other embodiments, a medicamentdelivery device can include a transdermal medicament delivery device, aninhaler or a nasal medicament delivery device.

Any of the monitoring devices, adapters and/or locators described hereincan be configured to send a signal in response to the detection of apotential emergency. For example, in some embodiments any of the devicesdescribed herein can be GPS-enabled, and can automatically dial anemergency number such as, for example, 911 (emergency dispatcher),and/or send information associated with the location of the deviceand/or the end user location through GPS satellite positioning ornetwork based positioning (using cell phone towers).

Although various embodiments have been described as having particularfeatures and/or combinations of components, other embodiments arepossible having a combination of any features and/or components from anyof embodiments where appropriate. For example, in some embodiments a kitcan include an electronic circuit system, two or more medicamentdelivery devices and a movable portion. In such embodiments, each of themedicament delivery devices can be associated with a switch. Moreover,the movable portion can also be associated with a switch. In thismanner, the electronic circuit system can be configured to output afirst electronic output when the movable portion is moved, a secondelectronic output when the first medicament delivery device is removedfrom the container and a third electronic output when the secondmedicament delivery device is removed from the container.

The medicament delivery devices described herein, such as the medicamentdelivery device 100, the medicament delivery device 21990 and any othersdescribed herein, can be any suitable medicament delivery device. Forexample, a medicament delivery device according to an embodiment caninclude a pen injector, an auto-injector, an inhaler or a transdermaldelivery device.

In some embodiments the medicament delivery devices and/or medicamentcontainers shown herein can include any suitable medicament, such as avaccine. Such vaccines can include, for example, an influenza A vaccine,an influenza B vaccine, an influenza A (H1N1) vaccine, a hepatitis Avaccine, a hepatitis B vaccine, a haemophilus influenza Type B (HiB)vaccine, a measles vaccine, a mumps vaccine, a rubella vaccine, a poliovaccine, a human papilloma virus (HPV) vaccine, a tetanus vaccine, adiphtheria vaccine, a pertussis vaccine, a bubonic plague vaccine, ayellow fever vaccine, a cholera vaccine, a malaria vaccine, a cancervaccine, a smallpox vaccine, a pneumococcal vaccine, a rotavirusvaccine, a varicella vaccine and/or a meningococcus vaccine. In otherembodiments, the medicament delivery devices and/or medicamentcontainers shown herein can include epinephrine. In other embodiments,the medicament contained within any of the medicament delivery devicesand/or medicament containers shown herein can be naloxone, including anyof the naloxone formulations described in U.S. patent application Ser.No. 13/036,720, entitled “Medicament Delivery Device for Administrationof Opioid Antagonists Including Formulation for Naloxone,” filed on Feb.28, 2011.

In other embodiments, the medicament contained within any of themedicament delivery devices and/or medicament containers shown hereincan include insulin, glucagon, human growth hormone (HGH),erythropoiesis-stimulating agents (ESA), denosumab, other monoclonalAntibodies (mAbs′), Interferon and other chronic therapies, or the like.Such formulations can be produced using a general lyophilization processwith glucagon (of recombinant origin) using bulking agents, stabilizers,buffers, acidifying agents or other excipients comprising of, but notlimited to, one or more of the following combinations: lactose,hydrochloric acid; glucose, histidine, hydrochloric acid; trehalose,mannitol, citrate; trehalose, mannitol, hydrochloric acid; trehalose,glycine, hydrochloric acid; Mannitol, ascorbic acid; and Glycine,hydrochloric acid.

In other embodiments any of the medicament delivery devices and/ormedicament containers described herein can be filled with and/or used toinject medicament formulations, including lyophilized biologics and/orbiopharmaceuticals, such as, for example, canakinumab, certolizumab,golimumab, and/or interleukins, for the treatment of crypyrin associatedperiodic syndromes, hereditary andioedema, and other auto-immunediseases. In yet other embodiments, any of the medicament deliverydevices and/or medicament containers described herein can be filled withand/or used to inject intranasal biologics, such as glucagon or humangrowth hormone, formulated for use in an auto injector, for thetreatment of musculoskeletal diseases, growth disorders, diabetes &treatment related disorders. Thus, although the medicament deliverydevices shown herein are primarily injectors, in other embodiments, amedicament delivery device need not be a medical injector, but rather,can be an inhaler, an intranasal delivery device or the like.

In other embodiments, any of the medicament delivery devices and/ormedicament containers described herein can be filled with and/or used toinject an anti-thrombolytic, such as LMWH, ULMWH, Xa Inhibitors,biotinylated idraparinux, etc., for either the acute management and/orsurgical prophylaxis of deep vein thrombosis and/or pulmonary embolismor for the management of other conditions which may requireanticoagulation to prevent thromboembolism, such as its use incardiovascular diseases including atrial fibrillation and ischemicstroke. In another example, in some embodiments an injector according toan embodiment can be filled with and/or used to inject formulations forthe treatment of asthma and/or chronic obstructive pulmonary disease.

In other embodiments, any of the medicament delivery devices and/ormedicament containers described herein can be filled with and/or used toinject recombinant hyaluronidase.

In other embodiments, any of the medicament delivery devices and/ormedicament containers described herein can be filled with and/or used toinject depot medroxyprogesterone acetate for the treatment ofinfertility.

In other embodiments, any of the medicament delivery devices and/ormedicament containers described herein can be filled with and/or used toinject environmental, food, and household allergen formulations for thetreatment of allergic disease, specifically for use in immunotherapy.

In still other embodiments, the medicament contained within any of themedicament delivery devices and/or medicament containers shown hereincan be a placebo substance (i.e., a substance with no activeingredients), such as water.

The medicament containers and/or medicament delivery devices disclosedherein can contain any suitable amount of any medicament. For example,in some embodiments, a medicament delivery device as shown herein can bea single-dose device containing an amount medicament to be delivered ofapproximately 0.4 mg, 0.8 mg, 1 mg, 1.6 mg or 2 mg. As described above,the fill volume can be such that the ratio of the delivery volume to thefill volume is any suitable value (e.g., 0.4, 0.6 or the like). In someembodiments, an electronic circuit system can include a “configurationswitch” (similar to any of the switches shown and described above, suchas the switch 6972) that, when actuated during the assembly of thedelivery device, can select an electronic output corresponding to thedose contained within the medicament container.

What is claimed is:
 1. A method, comprising: establishing acommunications link between a computing device and an adapter, theadapter configured to receive at least a portion of a medicamentdelivery device; receiving a wireless signal to maintain thecommunications link; determining a relative position between thecomputing device and the adapter; and producing an alarm when thewireless signal is not received within a time period, the alarm based onthe relative position between the computing device and the adapter. 2.The method of claim 1, wherein the medicament delivery device is any oneof an auto-injector, a nasal delivery device or an inhaler.
 3. Themethod of claim 1, wherein the establishing includes establishing thecommunications link via a short-range wireless protocol.
 4. The methodof claim 1, wherein the establishing includes transmitting a pagesignal.
 5. The method of claim 1, wherein the receiving the wirelesssignal includes receiving the wireless signal periodically.
 6. Themethod of claim 1, wherein the determining the relative positionincludes receiving a global positioning sensor (GPS) signal.
 7. Themethod of claim 1, wherein the producing the alarm includes producing atleast one of an audible alarm, a flashing light or a vibratory alarm. 8.The method of claim 1, wherein the computing device is a cell phone. 9.A method, comprising: establishing a communications link, via ashort-range wireless protocol, between a mobile computing device and amedicament delivery device, the mobile computing device including atouchscreen, the medicament delivery device including a case and anelectronic circuit system, the case configured to receive at least aportion of the medicament delivery device, the electronic circuit systemincluding a radio; receiving a wireless signal from the radio, thewireless signal associated with removal of the medicament deliverydevice from the case; producing, via at least one of the mobilecomputing device or the electronic circuit system, an alarm indicatingthat the medicament delivery device is in use; producing, via thetouchscreen and after the receiving the wireless signal, a promptassociated with a use instruction of the medicament delivery device;receiving, in response to the prompt, a user input; and transmitting, inresponse to the user input and via the touchscreen, the use instruction.10. The method of claim 9, wherein the medicament delivery device is anyone of an auto-injector, a nasal delivery device or an inhaler.
 11. Themethod of claim 9, wherein the medicament delivery device is anauto-injector configured to deliver at least one of a dose ofepinephrine, a dose of naloxone, or a dose of glucagon.